The following data is part of a premarket notification filed by Neomedix Corp. with the FDA for Trabectome High Frequency Generator/lp.
| Device ID | K061258 |
| 510k Number | K061258 |
| Device Name: | TRABECTOME HIGH FREQUENCY GENERATOR/LP |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | NEOMEDIX CORP. 15042 PARKWAY LOOP SUITE A Tustin, CA 92780 |
| Contact | Thomas Schroeder |
| Correspondent | Marc M Mouser UNDERWRITERS LABORATORIES, INC. 2600 NW LAKE RD. Camas, WA 98607 -9526 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2006-05-05 |
| Decision Date | 2006-05-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00854028002030 | K061258 | 000 |