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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 K193307
Device Name HIP7
Applicant
Brainlab AG
Olof-Palme-Str. 9
Munich,  DE 81829
Applicant Contact Cherita James
Correspondent
M Squared Associates Inc.
575 8th Ave
Suite 1212
New York,  NY  10018
Correspondent Contact Cherita James
Regulation Number882.4560
Classification Product Code
OLO  
Date Received11/29/2019
Decision Date 06/02/2020
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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