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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 K850529
Device Name SHEER ADHESIVE BANDAGES, STERILE
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 Received02/11/1985
Decision Date 05/10/1985
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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