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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
Predetermined Change
Control Plan Authorized		 No
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