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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthopedic Stereotaxic Instrument
510(k) Number K200845
Device Name Navigation Module of the Momentum System
Applicant
ulrich medical USA
18221 Edison Avenue
Chesterfield,  MO  63005
Applicant Contact Hans Stover
Correspondent
ulrich medical USA
18221 Edison Avenue
Chesterfield,  MO  63005
Correspondent Contact Hans Stover
Regulation Number882.4560
Classification Product Code
OLO  
Date Received03/31/2020
Decision Date 09/10/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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