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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bandage, Liquid
510(k) Number K940624
Device Name 3M TEGASORB HYDROCOLLOID DRESSING
Applicant
3M COMPANY
3M CENTER
BLDG. 275-3SE-08
ST. PAUL,  MN  55144 -1000
Applicant Contact BETTY L FALARDEAUX
Correspondent
3M COMPANY
3M CENTER
BLDG. 275-3SE-08
ST. PAUL,  MN  55144 -1000
Correspondent Contact BETTY L FALARDEAUX
Regulation Number880.5090
Classification Product Code
KMF  
Date Received02/14/1994
Decision Date 05/04/1994
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
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