The following data is part of a premarket notification filed by Optim, Llc. with the FDA for Electrode, Flexible Suction Coagulator.
| Device ID | K130489 |
| 510k Number | K130489 |
| Device Name: | ELECTRODE, FLEXIBLE SUCTION COAGULATOR |
| Classification | Electrode, Flexible Suction Coagulator |
| Applicant | OPTIM, LLC. 64 TECHNOLOGY PARK RD. Sturbridge, MA 01566 |
| Contact | Jeff Barrett, Ceo |
| Correspondent | Jeff Barrett, Ceo OPTIM, LLC. 64 TECHNOLOGY PARK RD. Sturbridge, MA 01566 |
| Product Code | FEH |
| CFR Regulation Number | 876.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-02-25 |
| Decision Date | 2013-04-19 |
| Summary: | summary |