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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tape And Bandage, Adhesive
510(k) Number K903823
Device Name SPEEDWRAP, DYNAWRAP, DYNAPLAST TAPE
Applicant
Smith and Nephew Donjoy, Inc.
2777 Loker Ave. W.
Carsbad,  CA  92008
Applicant Contact GREGORY R NELSON
Correspondent
Smith and Nephew Donjoy, Inc.
2777 Loker Ave. W.
Carsbad,  CA  92008
Correspondent Contact GREGORY R NELSON
Regulation Number880.5240
Classification Product Code
KGX  
Date Received08/20/1990
Decision Date 01/16/1991
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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