The following data is part of a premarket notification filed by Biolitec, Inc. with the FDA for Endovascular Laer Vein System Kit.
| Device ID | K101712 |
| 510k Number | K101712 |
| Device Name: | ENDOVASCULAR LAER VEIN SYSTEM KIT |
| Classification | Powered Laser Surgical Instrument |
| Applicant | BIOLITEC, INC. 1349 MAIN ROAD Granville, MA 01034 |
| Contact | Harry Hayes |
| Correspondent | Harry Hayes BIOLITEC, 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 | 2010-06-18 |
| Decision Date | 2010-10-27 |
| Summary: | summary |