The following data is part of a premarket notification filed by Fehling Instruments Gmbh & Co. Kg with the FDA for Biopsy Forceps.
Device ID | K170726 |
510k Number | K170726 |
Device Name: | Biopsy Forceps |
Classification | Device, Biopsy, Endomyocardial |
Applicant | Fehling Instruments GmbH & Co. KG Hanauer Landstr. 7A Karlstein, DE D-63791 |
Contact | Ulrike Lindner |
Correspondent | Arne Briest VISAMED GmbH Kastellstr, 8 Karlsruhe, DE D-76227 |
Product Code | DWZ |
CFR Regulation Number | 870.4075 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-03-09 |
Decision Date | 2017-06-02 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04058749000108 | K170726 | 000 |
04058749000023 | K170726 | 000 |
04058749000030 | K170726 | 000 |
04058749000047 | K170726 | 000 |
04058749000054 | K170726 | 000 |
04058749000061 | K170726 | 000 |
04058749000078 | K170726 | 000 |
04058749000085 | K170726 | 000 |
04058749000092 | K170726 | 000 |
04058749000016 | K170726 | 000 |