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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 K221115
Device Name Flow-Nail
Applicant
Flow-FX, LLC
9301 West 191st Street
Mokena,  IL  60448
Applicant Contact Patrick J. Sweeney
Correspondent
MCRA,LLC.
803 7th Street NW
Washington,  DC  20001
Correspondent Contact Hollace S. Rhodes
Regulation Number888.3020
Classification Product Code
HSB  
Date Received04/15/2022
Decision Date 05/13/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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