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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Toe, Constrained, Polymer
510(k) Number K191966
Device Name NewPrim System
Applicant
Brm Extremities
Via Ciro Menotti 10
Milano,  MI  20129
Applicant Contact Andrea De Maglio
Correspondent
Mcra, LLC
1050 K. St. NW
Suite 1000
Washington,  DC  20001
Correspondent Contact Margeaux Roger
Regulation Number888.3720
Classification Product Code
KWH  
Date Received07/23/2019
Decision Date 02/13/2020
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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