The following data is part of a premarket notification filed by Omniguide, Inc. with the FDA for Omniguide Beam Path Co2 Mark Iii Waveguide Fiber.
| Device ID | K070157 |
| 510k Number | K070157 |
| Device Name: | OMNIGUIDE BEAM PATH CO2 MARK III WAVEGUIDE FIBER |
| Classification | Powered Laser Surgical Instrument |
| Applicant | OMNIGUIDE, INC. ONE KENDALL SQUARE, BLDG 100 3RD FLOOR Cambridge, MA 02139 |
| Contact | Douglas W Woodruff |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2007-01-17 |
| Decision Date | 2007-02-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00894338002856 | K070157 | 000 |
| 00894338002849 | K070157 | 000 |
| 00894338002825 | K070157 | 000 |
| 00894338002672 | K070157 | 000 |