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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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