The following data is part of a premarket notification filed by Surgical Products Corp. with the FDA for Surgilase Fiberlase Vco2 Laser Waveguide.
| Device ID | K921671 |
| 510k Number | K921671 |
| Device Name: | SURGILASE FIBERLASE VCO2 LASER WAVEGUIDE |
| Classification | Powered Laser Surgical Instrument |
| Applicant | SURGICAL PRODUCTS CORP. 45 WEST ST. SUITE 2 Attleboro, MA 02703 |
| Contact | Lynnne Aronson |
| Correspondent | Lynnne Aronson SURGICAL PRODUCTS CORP. 45 WEST ST. SUITE 2 Attleboro, MA 02703 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-04-08 |
| Decision Date | 1992-06-18 |