The following data is part of a premarket notification filed by Fehling Instruments Gmbh & Co. Kg with the FDA for Fehling-punches.
Device ID | K153243 |
510k Number | K153243 |
Device Name: | Fehling-Punches |
Classification | Rongeur, Manual |
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 | HAE |
CFR Regulation Number | 882.4840 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-11-09 |
Decision Date | 2016-08-04 |
Summary: | summary |