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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 K952547
Device Name COVERSAN, ISLESAN
Applicant
Medical Device Development Co.
23 Valley Forge Ln.
Morris Plains,  NY 
Applicant Contact ARY CHERNOMORSKY
Correspondent
Medical Device Development Co.
23 Valley Forge Ln.
Morris Plains,  NY 
Correspondent Contact ARY CHERNOMORSKY
Regulation Number880.5090
Classification Product Code
KMF  
Date Received06/02/1995
Decision Date 08/14/1995
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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