The following data is part of a premarket notification filed by Thermedx, Llc with the FDA for Thermedx 37-5 Electrocautery Probes, Models Mpj200, Mpj210, Mps220, Mpn230, Bph240.
| Device ID | K102275 |
| 510k Number | K102275 |
| Device Name: | THERMEDX 37-5 ELECTROCAUTERY PROBES, MODELS MPJ200, MPJ210, MPS220, MPN230, BPH240 |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | THERMEDX, LLC 31200 SOLON ROAD UNIT 1 Solon, OH 44139 |
| Contact | John R Scoville |
| Correspondent | John R Scoville THERMEDX, LLC 31200 SOLON ROAD UNIT 1 Solon, OH 44139 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-08-11 |
| Decision Date | 2011-03-25 |
| Summary: | summary |