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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 K914596
Device Name SURGICAL CLOTH TAPE (HEALRITE)
Applicant
INDUSTRIAS TUK, S.A. DE C.V.
P.O. BOX 1868
64000 MONTEREY
N.L., MEXICO,  MX
Applicant Contact GUILLERMO A DOUNCE
Correspondent
INDUSTRIAS TUK, S.A. DE C.V.
P.O. BOX 1868
64000 MONTEREY
N.L., MEXICO,  MX
Correspondent Contact GUILLERMO A DOUNCE
Regulation Number880.5240
Classification Product Code
KGX  
Date Received10/16/1991
Decision Date 03/19/1992
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
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