The following data is part of a premarket notification filed by Microvision, Inc. with the FDA for Fiber Optic Endoillumination Probe.
| Device ID | K982462 |
| 510k Number | K982462 |
| Device Name: | FIBER OPTIC ENDOILLUMINATION PROBE |
| Classification | Image, Illumination, Fiberoptic, For Endoscope |
| Applicant | MICROVISION, INC. 34 FOLLY MILL RD. Seabrook, NH 03874 -1651 |
| Contact | Leonard Kastrilevich |
| Correspondent | Leonard Kastrilevich MICROVISION, INC. 34 FOLLY MILL RD. Seabrook, NH 03874 -1651 |
| Product Code | FFS |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-07-15 |
| Decision Date | 1998-09-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30818255011167 | K982462 | 000 |
| 30818255010443 | K982462 | 000 |
| 30818255010474 | K982462 | 000 |
| 30818255010658 | K982462 | 000 |
| 30818255010689 | K982462 | 000 |
| 30818255010726 | K982462 | 000 |
| 30818255010733 | K982462 | 000 |
| 30818255010740 | K982462 | 000 |
| 30818255010962 | K982462 | 000 |
| 30818255011044 | K982462 | 000 |
| 30818255011099 | K982462 | 000 |
| 30818255010160 | K982462 | 000 |