The following data is part of a premarket notification filed by Biolitec Medical Devices, Inc with the FDA for Radial-emitting Shaped Fiber Optic Delivery System.
| Device ID | K112442 |
| 510k Number | K112442 |
| Device Name: | RADIAL-EMITTING SHAPED FIBER OPTIC DELIVERY SYSTEM |
| Classification | Powered Laser Surgical Instrument |
| Applicant | BIOLITEC MEDICAL DEVICES, INC 1349 MAIN ROAD Granville, MA 01034 |
| Contact | Harry Hayes |
| Correspondent | Harry Hayes BIOLITEC MEDICAL DEVICES, INC 1349 MAIN ROAD Granville, MA 01034 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-08-24 |
| Decision Date | 2011-09-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00869851000399 | K112442 | 000 |
| 00859337007097 | K112442 | 000 |
| 00859337007080 | K112442 | 000 |
| 00859337007066 | K112442 | 000 |
| 00859337007011 | K112442 | 000 |
| 00859337007004 | K112442 | 000 |