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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 K853820
Device Name SURGICAL TAPES CLOTH, PAPER & PLASTIC-BASE
Applicant
ABCO DEALERS, INC.
P.O. BOX 17587
6637 NORTH SIDNEY PLACE
MILWAUKEE,  WI  53217
Applicant Contact PIYUSH M SHAH
Correspondent
ABCO DEALERS, INC.
P.O. BOX 17587
6637 NORTH SIDNEY PLACE
MILWAUKEE,  WI  53217
Correspondent Contact PIYUSH M SHAH
Regulation Number880.5240
Classification Product Code
KGX  
Date Received09/12/1985
Decision Date 10/16/1985
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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