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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Biopsy, Endomyocardial
510(k) Number K170726
Device Name Biopsy Forceps
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 Number870.4075
Classification Product Code
DWZ  
Date Received03/09/2017
Decision Date 06/02/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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