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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name rongeur, manual
510(k) Number K150468
Device Name Laminectomy Rongeurs, Kerrison Rongeurs, IVD Rongeurs
Applicant
K2 Medical GmbH & Co. KG
Unter Buchsteig 5
Tuttlingen,  DE
Applicant Contact Harald Jung
Correspondent
K2 Medical GmbH & Co. KG
Unter Buchsteig 5
Tuttlingen,  DE
Correspondent Contact Harald Jung
Regulation Number882.4840
Classification Product Code
HAE  
Date Received02/23/2015
Decision Date 02/29/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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