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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Rod, Fixation, Intramedullary And Accessories
510(k) Number K140601
Device Name FLOW-NAIL
Applicant
Flow-Fx, LLC
1331 H St. NW, 12th Floor
Regulatory Affairs Division
Washington,  DC  20005
Applicant Contact MICHELLE MCDONOUGH
Correspondent
Flow-Fx, LLC
1331 H St. NW, 12th Floor
Regulatory Affairs Division
Washington,  DC  20005
Correspondent Contact MICHELLE MCDONOUGH
Regulation Number888.3020
Classification Product Code
HSB  
Date Received03/10/2014
Decision Date 07/02/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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