The following data is part of a premarket notification filed by Linvatec Corp. with the FDA for Ultrablator Electrode.
| Device ID | K030720 |
| 510k Number | K030720 |
| Device Name: | ULTRABLATOR ELECTRODE |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | LINVATEC CORP. 11311 CONCEPT BLVD. Largo, FL 33773 -4908 |
| Contact | Laura D Seneff |
| Correspondent | Laura D Seneff LINVATEC CORP. 11311 CONCEPT BLVD. Largo, FL 33773 -4908 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-03-07 |
| Decision Date | 2003-06-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20845854029586 | K030720 | 000 |
| 20845854029579 | K030720 | 000 |
| 20845854020620 | K030720 | 000 |
| 20845854020606 | K030720 | 000 |
| 20845854029562 | K030720 | 000 |
| 20845854029555 | K030720 | 000 |
| 20845854029548 | K030720 | 000 |
| 20845854020613 | K030720 | 000 |
| 20845854020590 | K030720 | 000 |