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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 K990440
Device Name GENTELL HYDROGEL SPRAY GEL, APPLIGARD SQUEEZE
Applicant
Gentell
1667 K St. NW, Suite 700
Washington,  DC  20006
Applicant Contact MARK L ITZKOFF
Correspondent
Gentell
1667 K St. NW, Suite 700
Washington,  DC  20006
Correspondent Contact MARK L ITZKOFF
Classification Product Code
MGQ  
Date Received02/11/1999
Decision Date 08/12/1999
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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