The following data is part of a premarket notification filed by Conmed Linvatec with the FDA for Conmed Linvatec Smart Guard Irrigator.
| Device ID | K070233 |
| 510k Number | K070233 |
| Device Name: | CONMED LINVATEC SMART GUARD IRRIGATOR |
| Classification | Arthroscope |
| Applicant | CONMED LINVATEC 11311 CONCEPT BOULEVARD Largo, FL 33773 -4908 |
| Contact | Elizabeth M Paul |
| Correspondent | Elizabeth M Paul CONMED LINVATEC 11311 CONCEPT BOULEVARD Largo, FL 33773 -4908 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-01-25 |
| Decision Date | 2007-04-02 |
| Summary: | summary |