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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 K073213
Device Name THERABOND ANTIMICROBIAL BARRIER SYSTEMS
Applicant
CHOICE THERAPEUTICS
COLUMBIA SQUARE
555 THIRTEENTH STREET NW
WASHINGTON,  DC  20004
Applicant Contact HOWARD M HOLSTEIN
Correspondent
CHOICE THERAPEUTICS
COLUMBIA SQUARE
555 THIRTEENTH STREET NW
WASHINGTON,  DC  20004
Correspondent Contact HOWARD M HOLSTEIN
Classification Product Code
FRO  
Date Received11/14/2007
Decision Date 05/28/2008
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
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