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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 K201830
Device Name ANSER Clavicle Pin
Applicant
Baat Medical Products BV
F. Hazemeijerstraat 800 - Building A04
RJ Hengelo,  NL 7555
Applicant Contact Teake Bulstra
Correspondent
Baat Medical Products BV
F. Hazemeijerstraat 800 - Building A04
RJ Hengelo,  NL 7555
Correspondent Contact Teake Bulstra
Regulation Number888.3020
Classification Product Code
HSB  
Subsequent Product Code
JDW  
Date Received07/02/2020
Decision Date 08/27/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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