The following data is part of a premarket notification filed by Lagis Enterprises Co, Ltd. with the FDA for Lagis Endoscopic Instruments.
| Device ID | K090309 |
| 510k Number | K090309 |
| Device Name: | LAGIS ENDOSCOPIC INSTRUMENTS |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | LAGIS ENTERPRISES CO, LTD. 7128 STAFFORDSHIRE ST. Houston, TX 77030 |
| Contact | Joseph J Chang |
| Correspondent | Joseph J Chang LAGIS ENTERPRISES CO, LTD. 7128 STAFFORDSHIRE ST. Houston, TX 77030 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-02-06 |
| Decision Date | 2009-08-28 |
| Summary: | summary |