The following data is part of a premarket notification filed by Xintec Corporation with the FDA for Protege Er:yag Laser System And Accessories.
| Device ID | K971912 |
| 510k Number | K971912 |
| Device Name: | PROTEGE ER:YAG LASER SYSTEM AND ACCESSORIES |
| Classification | Powered Laser Surgical Instrument |
| Applicant | XINTEC CORPORATION 900 ALICE ST. Oakland, CA 94607 |
| Contact | Marilyn M Chou |
| Correspondent | Marilyn M Chou XINTEC CORPORATION 900 ALICE ST. Oakland, CA 94607 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-04-11 |
| Decision Date | 1997-11-03 |