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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 K945224
Device Name GRX FOAM DRESSING
Applicant
GERITREX CORP.
2 EAST SANFORD BLVD.
MOUNT VERNON,  NY  10550 -4510
Applicant Contact ANTHONY J MADAIO
Correspondent
GERITREX CORP.
2 EAST SANFORD BLVD.
MOUNT VERNON,  NY  10550 -4510
Correspondent Contact ANTHONY J MADAIO
Regulation Number880.5090
Classification Product Code
KMF  
Date Received10/26/1994
Decision Date 04/03/1995
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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