The following data is part of a premarket notification filed by Kls Martin Gmbh + Co. Kg with the FDA for Codman Electrosurgical Generator, Foot Pedal.
| Device ID | K183526 |
| 510k Number | K183526 |
| Device Name: | Codman Electrosurgical Generator, Foot Pedal |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | KLS Martin GmbH + Co. KG Am Flughafen 18 Freiburg Im Breisgau, DE 79108 |
| Contact | Hanna Huttmeyer |
| Correspondent | Hanna Huttmeyer KLS Martin GmbH + Co. KG Am Flughafen 18 Freiburg Im Breisgau, DE 79108 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-19 |
| Decision Date | 2019-04-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10886704081708 | K183526 | 000 |
| 10886704081685 | K183526 | 000 |
| 10381780530374 | K183526 | 000 |
| 10381780532880 | K183526 | 000 |
| 10381780532866 | K183526 | 000 |