The following data is part of a premarket notification filed by Kls-martin L.p. with the FDA for Kls Martin Neuro Rongeurs.
| Device ID | K210741 |
| 510k Number | K210741 |
| Device Name: | KLS Martin Neuro Rongeurs |
| Classification | Rongeur, Manual |
| Applicant | KLS-MARTIN L.P. 11201 Saint Johns Industrial Parkway South Jacksonville, FL 32246 |
| Contact | Jennifer Damato |
| Correspondent | Susan Leander KLS-MARTIN L.P. 11201 Saint Johns Industrial Parkway South Jacksonville, FL 32246 |
| Product Code | HAE |
| CFR Regulation Number | 882.4840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-03-12 |
| Decision Date | 2022-06-03 |