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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 K914912
Device Name PROMEON 63B SURGICAL TAPE
Applicant
Promeon
6700 Shingle Creek Pkwy.
Brooklyn Center,  MN  55430
Applicant Contact DAVID H MUELLER
Correspondent
Promeon
6700 Shingle Creek Pkwy.
Brooklyn Center,  MN  55430
Correspondent Contact DAVID H MUELLER
Regulation Number880.5240
Classification Product Code
KGX  
Date Received11/01/1991
Decision Date 12/04/1991
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
Predetermined Change
Control Plan Authorized		 No
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