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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wound Dressings Containing Topical Analgesics
510(k) Number K092086
FOIA Releasable 510(k) K092086
Device Name AMERIGEL WOUND DRESSING PLUS 1/2 OZ. (15G TUBE), MODEL A2025; 1 OZ. (30G TUBE), MODEL A2026; 3 OZ (90G TUBE),MODEL A2027
Applicant
Amerx Health Care Corp.
1300 S. Highland Ave.
Clearwater,  FL  33756
Applicant Contact ART W SIMONETTI, LPN
Correspondent
Amerx Health Care Corp.
1300 S. Highland Ave.
Clearwater,  FL  33756
Correspondent Contact ART W SIMONETTI, LPN
Classification Product Code
SEJ  
Date Received07/09/2009
Decision Date 07/30/2009
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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