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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Holder, Head, Neurosurgical (Skull Clamp)
510(k) Number K250423
Device Name mb-FIX Cranial Stabilization Systems
Applicant
Medical Bees GmbH
Friedrich-Woehler-Strasse 13
Emmingen-Liptingen,  DE 78576
Applicant Contact Laura Sperle
Correspondent
Business Support International
Aalsmeerweg 123-3
Amsterdam,  NL 1059AH
Correspondent Contact Angelika Scherp
Regulation Number882.4460
Classification Product Code
HBL  
Date Received02/14/2025
Decision Date 11/06/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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