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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
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