The following data is part of a premarket notification filed by Linvatec Corp. with the FDA for Apex Universal Irrigation System & Two-connection Tubing Set.
| Device ID | K961590 |
| 510k Number | K961590 |
| Device Name: | APEX UNIVERSAL IRRIGATION SYSTEM & TWO-CONNECTION TUBING SET |
| Classification | Arthroscope |
| Applicant | LINVATEC CORP. 11311 CONCEPT BLVD. Largo, FL 33773 -4908 |
| Contact | Carol A Weideman |
| Correspondent | Carol A Weideman 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 | 1996-04-24 |
| Decision Date | 1996-10-08 |