The following data is part of a premarket notification filed by New Star Lasers, Inc. with the FDA for Temperature Diagnostic Accessory.
| Device ID | K973764 |
| 510k Number | K973764 |
| Device Name: | TEMPERATURE DIAGNOSTIC ACCESSORY |
| Classification | Powered Laser Surgical Instrument |
| Applicant | NEW STAR LASERS, INC. 11802 KEMPER RD. Auburn, CA 95603 |
| Contact | Dave Hennings |
| Correspondent | Dave Hennings NEW STAR LASERS, INC. 11802 KEMPER RD. Auburn, CA 95603 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-10-02 |
| Decision Date | 1997-12-31 |
| Summary: | summary |