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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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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