The following data is part of a premarket notification filed by Omniguide, Inc. with the FDA for Omniguide Beampath Fiber Optic Handpiece System And Sterilization Tray.
| Device ID | K081939 |
| 510k Number | K081939 |
| Device Name: | OMNIGUIDE BEAMPATH FIBER OPTIC HANDPIECE SYSTEM AND STERILIZATION TRAY |
| 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 | 2008-07-08 |
| Decision Date | 2008-08-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00852306007319 | K081939 | 000 |
| 00852306007142 | K081939 | 000 |
| 00852306007135 | K081939 | 000 |
| 00852306007128 | K081939 | 000 |
| 00852306007111 | K081939 | 000 |
| 00852306007104 | K081939 | 000 |
| 00852306007098 | K081939 | 000 |
| 00852306007081 | K081939 | 000 |
| 00852306007074 | K081939 | 000 |
| 00852306007067 | K081939 | 000 |
| 00852306007050 | K081939 | 000 |
| 00852306007043 | K081939 | 000 |
| 00852306007036 | K081939 | 000 |
| 00852306007029 | K081939 | 000 |
| 00852306007012 | K081939 | 000 |
| 00852306007159 | K081939 | 000 |
| 00852306007166 | K081939 | 000 |
| 00852306007302 | K081939 | 000 |
| 00852306007296 | K081939 | 000 |
| 00852306007289 | K081939 | 000 |
| 00852306007272 | K081939 | 000 |
| 00852306007265 | K081939 | 000 |
| 00852306007258 | K081939 | 000 |
| 00852306007241 | K081939 | 000 |
| 00852306007234 | K081939 | 000 |
| 00852306007227 | K081939 | 000 |
| 00852306007210 | K081939 | 000 |
| 00852306007203 | K081939 | 000 |
| 00852306007197 | K081939 | 000 |
| 00852306007180 | K081939 | 000 |
| 00852306007173 | K081939 | 000 |
| 00852306007005 | K081939 | 000 |