The following data is part of a premarket notification filed by Fiberoptic Fabrications Inc with the FDA for Fiberoptic Laser Delivery System.
| Device ID | K120810 |
| 510k Number | K120810 |
| Device Name: | FIBEROPTIC LASER DELIVERY SYSTEM |
| Classification | Powered Laser Surgical Instrument |
| Applicant | FIBEROPTIC FABRICATIONS INC 495 MAIN STREET Wilbraham, MA 01095 |
| Contact | Carol J Morello |
| Correspondent | Carol J Morello FIBEROPTIC FABRICATIONS INC 495 MAIN STREET Wilbraham, MA 01095 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-03-16 |
| Decision Date | 2012-06-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00861062000342 | K120810 | 000 |
| 00861062000335 | K120810 | 000 |
| 00861062000328 | K120810 | 000 |
| 00861062000311 | K120810 | 000 |
| 00861062000304 | K120810 | 000 |
| 00861062000359 | K120810 | 000 |