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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 K193438
Device Name DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable Skull Pins (Titanium)
Applicant
Pro Med Instruments GmbH
Boetzinger St. 38
Freiburg,  DE 79111
Applicant Contact Muhammad Zubair
Correspondent
Pro Med Instruments GmbH
Boetzinger St. 38
Freiburg,  DE 79111
Correspondent Contact Muhammad Zubair
Regulation Number882.4460
Classification Product Code
HBL  
Date Received12/11/2019
Decision Date 06/02/2020
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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