The following data is part of a premarket notification filed by Linvatec Corp. with the FDA for Ablator Electrode.
| Device ID | K983652 |
| 510k Number | K983652 |
| Device Name: | ABLATOR ELECTRODE |
| Classification | Arthroscope |
| 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 | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-10-19 |
| Decision Date | 1999-03-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20845854035600 | K983652 | 000 |
| 10845854035597 | K983652 | 000 |
| 20845854035587 | K983652 | 000 |
| 10845854035573 | K983652 | 000 |
| 20845854027056 | K983652 | 000 |
| 20845854027049 | K983652 | 000 |
| 10845854027059 | K983652 | 000 |
| 10845854027042 | K983652 | 000 |
| 20845854029531 | K983652 | 000 |