The following data is part of a premarket notification filed by Linvatec Corp. with the FDA for Linvatec 10k Irrigation System.
| Device ID | K033573 |
| 510k Number | K033573 |
| Device Name: | LINVATEC 10K IRRIGATION SYSTEM |
| Classification | Arthroscope |
| Applicant | LINVATEC CORP. 11311 CONCEPT BLVD. Largo, FL 33773 -4908 |
| Contact | Laura D Krejci |
| Correspondent | Laura D Krejci 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 | 2003-11-13 |
| Decision Date | 2004-02-11 |
| Summary: | summary |