POLYVAC SURGICAL INSTRUMENT DELIVERY SYSTEM

Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

SYMMETRY MEDICAL, INC.

The following data is part of a premarket notification filed by Symmetry Medical, Inc. with the FDA for Polyvac Surgical Instrument Delivery System.

Pre-market Notification Details

• Device ID: K012105
• 510k Number: K012105
• Device Name: POLYVAC SURGICAL INSTRUMENT DELIVERY SYSTEM
• Classification: Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
• Applicant: SYMMETRY MEDICAL, INC. 220 WEST MARKET Warsaw, IN 46580
• Contact: D. Darin Martin
• Correspondent: D. Darin Martin; SYMMETRY MEDICAL, INC. 220 WEST MARKET Warsaw, IN 46580
• Product Code: KCT
• CFR Regulation Number: 880.6850 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2001-07-05
• Decision Date: 2002-08-02
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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