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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 K081246
Device Name TT-102
Applicant
Tissue Technologies Holdings, LLC
800 E. Leigh St., Suite 51
Richmond,  VA  23219
Applicant Contact YOUSEF MOHAJER
Correspondent
Tissue Technologies Holdings, LLC
800 E. Leigh St., Suite 51
Richmond,  VA  23219
Correspondent Contact YOUSEF MOHAJER
Classification Product Code
FRO  
Date Received05/01/2008
Decision Date 08/13/2009
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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