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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name dressing, wound and burn, hydrogel w/drug and/or biologic
510(k) Number K970133
Device Name AMERIGEL OINTMENT
Applicant
AMERX HEALTH CARE CORP.
1150 CLEVELAND ST.
SUITE 410
CLEARWATER,  FL  34615
Applicant Contact RONALD L MADDIX
Correspondent
AMERX HEALTH CARE CORP.
1150 CLEVELAND ST.
SUITE 410
CLEARWATER,  FL  34615
Correspondent Contact RONALD L MADDIX
Classification Product Code
MGQ  
Date Received01/15/1997
Decision Date 04/14/1997
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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