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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 K932422
Device Name 3M TEGADERM HP TRANSPARENT DRESSING
Applicant
3M HEALTH CARE, LTD.
3M CENTER, BLDG. 275-3E-08
P.O. BOX 33275
ST. PAUL,  MN  55133
Applicant Contact SUZANNE M DANIELSON
Correspondent
3M HEALTH CARE, LTD.
3M CENTER, BLDG. 275-3E-08
P.O. BOX 33275
ST. PAUL,  MN  55133
Correspondent Contact SUZANNE M DANIELSON
Regulation Number880.5240
Classification Product Code
KGX  
Date Received05/19/1993
Decision Date 12/27/1993
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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