The following data is part of a premarket notification filed by Inframed, Inc. with the FDA for Model Tt25rf.
| Device ID | K844178 |
| 510k Number | K844178 |
| Device Name: | MODEL TT25RF |
| Classification | Powered Laser Surgical Instrument |
| Applicant | INFRAMED, INC. P.O. BOX 761 Brookline Village, MA 02147 |
| Contact | Raymond F Fennessey |
| Correspondent | Raymond F Fennessey INFRAMED, INC. P.O. BOX 761 Brookline Village, MA 02147 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-10-26 |
| Decision Date | 1985-10-18 |