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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 K861525
Device Name DISPOSABLE SURG KITS/GOWNS/GUARDS/COVERS/MASKS
Applicant
D & D Products, Inc.
3711 Long Beach Blvd.,
Suite 618
Long Beach,  CA  90807
Applicant Contact DENNIS PACK
Correspondent
D & D Products, Inc.
3711 Long Beach Blvd.,
Suite 618
Long Beach,  CA  90807
Correspondent Contact DENNIS PACK
Regulation Number878.4800
Classification Product Code
FSM  
Date Received04/18/1986
Decision Date 05/06/1986
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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