The following data is part of a premarket notification filed by Linvatec Corp. with the FDA for Ultrablator Electrode.
| Device ID | K993885 |
| 510k Number | K993885 |
| Device Name: | ULTRABLATOR ELECTRODE |
| Classification | Electrode, Electrosurgical |
| Applicant | LINVATEC CORP. 11311 CONCEPT BLVD. Largo, FL 33773 -4908 |
| Contact | Laura Seneff |
| Correspondent | Laura Seneff LINVATEC CORP. 11311 CONCEPT BLVD. Largo, FL 33773 -4908 |
| Product Code | JOS |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-11-16 |
| Decision Date | 2000-02-10 |
| Summary: | summary |