Get the free 510(k) Summary CANOPY TM Laminoplasty Fixation System - accessdata fda
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510(k) Summary: CANOPY TM Rhinoplasty Fixation System Company: Contact: Globes Medical Inc. 2560 General Farmstead Ave. Audubon, PA 19403 6109301800 Sarah Marie Fitzgerald Project Manager, Regulatory
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What is 510k summary canopy tm?
The 510(k) summary for Canopy TM is a condensed version of the supporting data submitted to the FDA to demonstrate the safety and effectiveness of a medical device.
Who is required to file 510k summary canopy tm?
Manufacturers or sponsors of medical devices seeking FDA clearance through the 510(k) process are required to file a 510(k) summary for Canopy TM.
How to fill out 510k summary canopy tm?
To fill out the 510(k) summary for Canopy TM, manufacturers or sponsors should provide a concise overview of the device, its intended use, predicate device comparisons, testing data, and a summary of clinical studies.
What is the purpose of 510k summary canopy tm?
The purpose of the 510(k) summary for Canopy TM is to provide a brief and clear summary of the supporting data for a medical device's safety and effectiveness, assisting the FDA in making clearance decisions.
What information must be reported on 510k summary canopy tm?
The 510(k) summary for Canopy TM should include information such as device description, intended use, comparison to predicate devices, performance testing results, and summaries of clinical studies.
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