The following data is part of a premarket notification filed by Innovaquartz with the FDA for Sureflex And Accuflex Laser Lithotripsy Fibers.
| Device ID | K050108 |
| 510k Number | K050108 |
| Device Name: | SUREFLEX AND ACCUFLEX LASER LITHOTRIPSY FIBERS |
| Classification | Powered Laser Surgical Instrument |
| Applicant | INNOVAQUARTZ 23030 NORTH 15TH AVE. Phoenix, AZ 85027 |
| Contact | Steve Griffin |
| Correspondent | Steve Griffin INNOVAQUARTZ 23030 NORTH 15TH AVE. Phoenix, AZ 85027 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-01-18 |
| Decision Date | 2005-03-14 |
| Summary: | summary |