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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 K901845
Device Name TEGADERM BRAND TRANSPARENT DRESSING SERIES 16XX
Applicant
3M COMPANY
CHEMOLITE BLVD. & WASHINGTON
CITY RD. 19
COTTAE GROVE,  MN  55016
Applicant Contact CHARLES W OPP
Correspondent
3M COMPANY
CHEMOLITE BLVD. & WASHINGTON
CITY RD. 19
COTTAE GROVE,  MN  55016
Correspondent Contact CHARLES W OPP
Regulation Number880.5240
Classification Product Code
KGX  
Date Received04/24/1990
Decision Date 07/23/1990
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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