The following data is part of a premarket notification filed by Mederi Therapeutics Inc. with the FDA for Mederi Therapeutics Rf Generator Control Module.
| Device ID | K103017 |
| 510k Number | K103017 |
| Device Name: | MEDERI THERAPEUTICS RF GENERATOR CONTROL MODULE |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | MEDERI THERAPEUTICS INC. 80 SHELTON TECHNOLOGY CENTER Shelton, CT 06484 |
| Contact | Curt Raymond |
| Correspondent | Curt Raymond MEDERI THERAPEUTICS INC. 80 SHELTON TECHNOLOGY CENTER Shelton, CT 06484 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-10-12 |
| Decision Date | 2011-01-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00856219002102 | K103017 | 000 |