The following data is part of a premarket notification filed by Kls Martin Gmbh + Co. Kg with the FDA for Conmed Beamer System C600.
| Device ID | K081678 |
| 510k Number | K081678 |
| Device Name: | CONMED BEAMER SYSTEM C600 |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | KLS MARTIN GMBH + CO. KG AM GANSACKER 1B Umkirch, DE 79224 |
| Contact | Bernhard Hug |
| Correspondent | Stefan Preiss TUV SUD AMERICA INC. 1775 OLD HIGHWAY 8 NW New Brighton, MN 55112 -1891 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2008-06-17 |
| Decision Date | 2008-07-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04057607000182 | K081678 | 000 |
| 04057607000175 | K081678 | 000 |
| 04057607000168 | K081678 | 000 |
| 04057607000151 | K081678 | 000 |
| 04057607000144 | K081678 | 000 |
| 04057607000137 | K081678 | 000 |
| 04057607000120 | K081678 | 000 |
| 04057607000113 | K081678 | 000 |
| 04057607000106 | K081678 | 000 |