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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 K980117
Device Name NUVO BARRIER FILM
Applicant
BIOMEDICAL DEVELOPMENT CO.
6401 MEADOWS WEST DR.
FORT WORTH,  TX  76132
Applicant Contact RICHARD A HAMER
Correspondent
BIOMEDICAL DEVELOPMENT CO.
6401 MEADOWS WEST DR.
FORT WORTH,  TX  76132
Correspondent Contact RICHARD A HAMER
Regulation Number880.5090
Classification Product Code
KMF  
Date Received01/13/1998
Decision Date 12/18/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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