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51 0(k) Summary Submitted by: Oscar Inc. 3816 De Soto Blvd. Palm Harbor, FL. 34683OCT 2 0 2010October 12, 2010 This 51 0(k) Summary of Safety and Effectiveness information is being submitted in accordance
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Oscor Inc is a medical device company specializing in the development and manufacturing of advanced catheter systems and other related products for use in various medical procedures.
Entities engaged in certain medical device activities, including manufacturers and distributors of devices that fall under specific regulatory requirements, are typically required to file OSCP (Oscor Inc) documentation.
To fill out OSCP Inc, the entity must gather necessary information, complete the required forms including details on the products, manufacturing processes, and compliance with regulations, and submit them to the appropriate regulatory body.
The purpose of OSCP Inc is to ensure that manufacturers and distributors of medical devices comply with regulatory standards, thereby ensuring safety and effectiveness in medical practices.
Information that typically must be reported includes device descriptions, manufacturing processes, safety data, compliance with quality standards, and any previous incidents or recalls related to the product.
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