The following data is part of a premarket notification filed by Linvatec Corp. with the FDA for Shaver Ablator.
| Device ID | K002088 |
| 510k Number | K002088 |
| Device Name: | SHAVER ABLATOR |
| 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 | 2000-07-11 |
| Decision Date | 2001-03-06 |