The following data is part of a premarket notification filed by Spectragenics, Inc. with the FDA for Spectragenics Ats-1.
| Device ID | K060567 |
| 510k Number | K060567 |
| Device Name: | SPECTRAGENICS ATS-1 |
| Classification | Powered Laser Surgical Instrument |
| Applicant | SPECTRAGENICS, INC. 5880 WEST LAS POSITAS BLVD. SUITE 52 Pleasanton, CA 94588 |
| Contact | Robert E Groves |
| Correspondent | Robert E Groves SPECTRAGENICS, INC. 5880 WEST LAS POSITAS BLVD. SUITE 52 Pleasanton, CA 94588 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-03-03 |
| Decision Date | 2006-04-28 |
| Summary: | summary |