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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 K954274
Device Name MEPORE (6X7)
Applicant
Scott Health Care
100 E. 15th St.,Suite 320
Fort Worth,  TX  76102
Applicant Contact RICHARD A HAMMER
Correspondent
Scott Health Care
100 E. 15th St.,Suite 320
Fort Worth,  TX  76102
Correspondent Contact RICHARD A HAMMER
Regulation Number880.5090
Classification Product Code
KMF  
Date Received09/13/1995
Decision Date 12/19/1995
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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