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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, Drug
510(k) Number K090092
Device Name SOCKIT! AND MCMERLIN DERMAL WOUND GEL
Applicant
Mcmerlin Dental Products LP
1610 W. Polo Rd.
Grand Prairie,  TX  75052
Applicant Contact AARON HENDERSHOTT
Correspondent
Mcmerlin Dental Products LP
1610 W. Polo Rd.
Grand Prairie,  TX  75052
Correspondent Contact AARON HENDERSHOTT
Classification Product Code
FRO  
Date Received01/14/2009
Decision Date 05/11/2009
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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