The following data is part of a premarket notification filed by K2 Medical Gmbh & Co. Kg with the FDA for Laminectomy Rongeurs, Kerrison Rongeurs, Ivd Rongeurs.
| Device ID | K150468 |
| 510k Number | K150468 |
| Device Name: | Laminectomy Rongeurs, Kerrison Rongeurs, IVD Rongeurs |
| Classification | Rongeur, Manual |
| Applicant | K2 Medical GmbH & Co. KG Unter Buchsteig 5 Tuttlingen, DE |
| Contact | Harald Jung |
| Correspondent | Harald Jung K2 Medical GmbH & Co. KG Unter Buchsteig 5 Tuttlingen, DE |
| Product Code | HAE |
| CFR Regulation Number | 882.4840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-02-23 |
| Decision Date | 2016-02-29 |
| Summary: | summary |