The following data is part of a premarket notification filed by Xintec Corporation with the FDA for Protege Ii Er: Yag Laser System And Accessoies (upgrade).
| Device ID | K981627 |
| 510k Number | K981627 |
| Device Name: | PROTEGE II ER: YAG LASER SYSTEM AND ACCESSOIES (UPGRADE) |
| 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 | 1998-05-07 |
| Decision Date | 1998-07-31 |