The following data is part of a premarket notification filed by Linvatec Corp. with the FDA for Trident Resection Ablator.
| Device ID | K033748 |
| 510k Number | K033748 |
| Device Name: | TRIDENT RESECTION ABLATOR |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | LINVATEC CORP. 11311 CONCEPT BLVD. Largo, FL 33773 -4908 |
| Contact | Laura D Krejci |
| Correspondent | Laura D Krejci LINVATEC CORP. 11311 CONCEPT BLVD. Largo, FL 33773 -4908 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-12-01 |
| Decision Date | 2003-12-15 |
| Summary: | summary |