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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 K234075
Device Name Flow-Nail
Applicant
Flow-Fx, LLC
9301 W. 191st St.
Mokena,  IL  60448
Applicant Contact Patrick Sweeney
Correspondent
MCRA, LLC
803 7th St., NW, 3rd Floor
Washington, Dc,  DC  20001
Correspondent Contact Hollace Rhodes
Regulation Number888.3020
Classification Product Code
HSB  
Date Received01/10/2024
Decision Date 02/05/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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