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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 K153243
Device Name Fehling-Punches
Applicant
Fehling Instruments GmbH & Co. KG
Hanauer Landstr. 7A
Karlstein,  DE D-63791
Applicant Contact Ulrike Lindner
Correspondent
VISAMED GmbH
Kastellstr, 8
Karlsruhe,  DE D-76227
Correspondent Contact Arne Briest
Regulation Number882.4840
Classification Product Code
HAE  
Date Received11/09/2015
Decision Date 08/04/2016
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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