The following data is part of a premarket notification filed by Conmed Corporation with the FDA for Beamer Argon Probe.
| Device ID | K081644 |
| 510k Number | K081644 |
| Device Name: | BEAMER ARGON PROBE |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | CONMED CORPORATION 129 CONCORD RD. BLDG. #3 Billerica, MA 01821 |
| Contact | Karen Provencher |
| Correspondent | Jay Y Kogoma INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2008-06-12 |
| Decision Date | 2008-09-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10653405056461 | K081644 | 000 |
| 10653405056454 | K081644 | 000 |
| 10653405056447 | K081644 | 000 |
| 10653405056430 | K081644 | 000 |
| 20653405986468 | K081644 | 000 |
| 10653405056478 | K081644 | 000 |