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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
510(k) Number K012105
Device Name POLYVAC SURGICAL INSTRUMENT DELIVERY SYSTEM
Applicant
Symmetry Medical, Inc.
220 W. Market
Warsaw,  IN  46580
Applicant Contact D. DARIN MARTIN
Correspondent
Johnson & Johnson Surgical Vision, Inc.
31 Technology Dr., Suite 200
Irvine,  CA  92618
Correspondent Contact Danielle Stowe
Regulation Number880.6850
Classification Product Code
KCT  
Date Received07/05/2001
Decision Date 08/02/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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