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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tray, Surgical, Instrument
510(k) Number K871478
Device Name SURGICAL PACKS, SURGICAL KITS AND SURGICAL TRAYS
Applicant
Procedure Pak, Inc.
P.O. Box 15798
Asheville,  NC  28813
Applicant Contact JOHN FLIGEL
Correspondent
Procedure Pak, Inc.
P.O. Box 15798
Asheville,  NC  28813
Correspondent Contact JOHN FLIGEL
Regulation Number878.4800
Classification Product Code
FSM  
Date Received04/14/1987
Decision Date 05/07/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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