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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 K240319
Device Name DORO LUCENT Skull Clamp (1101.001); DORO LUCENT Skull Clamp Pediatric Set (1101.040)
Applicant
Pro Med Instruments GmbH
Bötzinger Straße 86
Freiburg,  DE 79111
Applicant Contact Rabel Talpur
Correspondent
Pro Med Instruments GmbH
Bötzinger Straße 86
Freiburg,  DE 79111
Correspondent Contact Rabel Talpur
Regulation Number882.4460
Classification Product Code
HBL  
Date Received02/02/2024
Decision Date 04/24/2024
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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