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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 K932743
Device Name MEFIX(R) ADHESIVE FABRIC FOR DRESSING FIXATION
Applicant
SCOTT HEALTH CARE
P.O. BOX 16598
FT. WORTH,  TX  76162
Applicant Contact LARRY BOGART
Correspondent
SCOTT HEALTH CARE
P.O. BOX 16598
FT. WORTH,  TX  76162
Correspondent Contact LARRY BOGART
Regulation Number880.5240
Classification Product Code
KGX  
Date Received06/08/1993
Decision Date 09/10/1993
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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