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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 K915477
Device Name STERILIZATION BAG, POLYESTER/WRAP
Applicant
Cgs Supplies Corp.
4736 NE 12th Ave.
Fort Lauderdale,  FL  33334
Applicant Contact CHARLES GUBERNICK
Correspondent
Cgs Supplies Corp.
4736 NE 12th Ave.
Fort Lauderdale,  FL  33334
Correspondent Contact CHARLES GUBERNICK
Regulation Number880.6850
Classification Product Code
KCT  
Date Received12/06/1991
Decision Date 05/08/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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