The following data is part of a premarket notification filed by Biolitec Medical Devices, Inc with the FDA for Twister Side Fire Optical Fiber Delivery System.
| Device ID | K112987 |
| 510k Number | K112987 |
| Device Name: | TWISTER SIDE FIRE OPTICAL FIBER DELIVERY SYSTEM |
| Classification | Powered Laser Surgical Instrument |
| Applicant | BIOLITEC MEDICAL DEVICES, INC 1349 MAIN ROAD Grandville, MA 01034 |
| Contact | Hary Hayes |
| Correspondent | Hary Hayes BIOLITEC MEDICAL DEVICES, INC 1349 MAIN ROAD Grandville, 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 | 2011-10-06 |
| Decision Date | 2011-12-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00869851000344 | K112987 | 000 |
| 00859337007028 | K112987 | 000 |
| 00859337007035 | K112987 | 000 |
| 00859337007042 | K112987 | 000 |
| 00859337007103 | K112987 | 000 |
| 00869851000306 | K112987 | 000 |
| 00869851000313 | K112987 | 000 |
| 00869851000320 | K112987 | 000 |
| 00869851000337 | K112987 | 000 |
| 00859337007141 | K112987 | 000 |