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This document contains the 510(k) summary for the TROJAN® MAGNUM® Latex Condom with FIRE & ICE™ Lubricant, detailing its technological characteristics, indications for use, and safety studies.
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How to fill out trojan_magnum_latex_condom_with_fire__ice_lubricant_510k_notification - accessdata fda
How to fill out TROJAN_MAGNUM_Latex_Condom_with_FIRE_&_ICE_Lubricant_510k_Notification
01
Gather all necessary documentation required for the 510k submission.
02
Complete the 510k application form, ensuring all information is accurate.
03
Prepare a detailed description of the TROJAN MAGNUM Latex Condom and FIRE & ICE Lubricant, including its intended use and specifications.
04
Include any relevant labeling and packaging information that complies with FDA regulations.
05
Attach any clinical data or research supporting the safety and effectiveness of the product.
06
Provide a summary of any similar FDA-approved devices, with appropriate comparisons.
07
Review the entire application for completeness and accuracy before submission.
08
Submit the application electronically through the FDA's submission portal and pay any required fees.
Who needs TROJAN_MAGNUM_Latex_Condom_with_FIRE_&_ICE_Lubricant_510k_Notification?
01
Manufacturers looking to market a new sexual health product that combines latex condoms with lubricants.
02
Healthcare professionals seeking to understand the regulatory process for condom and lubricant products.
03
Regulatory affairs specialists involved in the approval process of personal care products.
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What is TROJAN_MAGNUM_Latex_Condom_with_FIRE_&_ICE_Lubricant_510k_Notification?
TROJAN_MAGNUM_Latex_Condom_with_FIRE_&_ICE_Lubricant_510k_Notification is a pre-market submission made to the FDA for the purpose of obtaining clearance to market this specific condom product that includes fire and ice lubricants, ensuring it meets safety and efficacy standards.
Who is required to file TROJAN_MAGNUM_Latex_Condom_with_FIRE_&_ICE_Lubricant_510k_Notification?
Manufacturers or distributors of the TROJAN MAGNUM Latex Condom with FIRE & ICE Lubricant are required to file the 510k notification to demonstrate that the product is safe and effective for consumer use.
How to fill out TROJAN_MAGNUM_Latex_Condom_with_FIRE_&_ICE_Lubricant_510k_Notification?
To fill out the TROJAN MAGNUM Latex Condom with FIRE & ICE Lubricant 510k Notification, one must provide detailed information about the product, including descriptions, intended use, labeling, performance testing results, and any clinical data that supports the product's safety and effectiveness.
What is the purpose of TROJAN_MAGNUM_Latex_Condom_with_FIRE_&_ICE_Lubricant_510k_Notification?
The purpose of the notification is to inform the FDA of the product's safety and effectiveness, and to obtain clearance for marketing in the U.S. by demonstrating that it is substantially equivalent to a legally marketed predicate device.
What information must be reported on TROJAN_MAGNUM_Latex_Condom_with_FIRE_&_ICE_Lubricant_510k_Notification?
The information reported must include the product's design and materials, manufacturing processes, performance testing data, labeling, intended use, and any adverse event history related to similar devices.
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