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FDA 510(k) Application Details - K170726
Device Classification Name
Device, Biopsy, Endomyocardial
More FDA Info for this Device
510(K) Number
K170726
Device Name
Device, Biopsy, Endomyocardial
Applicant
Fehling Instruments GmbH & Co. KG
Hanauer Landstr. 7A
Karlstein D-63791 DE
Other 510(k) Applications for this Company
Contact
Ulrike Lindner
Other 510(k) Applications for this Contact
Regulation Number
870.4075
More FDA Info for this Regulation Number
Classification Product Code
DWZ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/09/2017
Decision Date
06/02/2017
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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