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 |