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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 K971918
Device Name AMERIGEL OINTMENT SATURATED WOUND DRESSING
Applicant
AMERX HEALTH CARE CORP.
1150 CLEVELAND ST.
SUITE 410
CLEARWATER,  FL  34615
Applicant Contact RON MADDIX
Correspondent
AMERX HEALTH CARE CORP.
1150 CLEVELAND ST.
SUITE 410
CLEARWATER,  FL  34615
Correspondent Contact RON MADDIX
Classification Product Code
MGQ  
Date Received05/23/1997
Decision Date 08/12/1997
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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