The following data is part of a premarket notification filed by Tava Surgical Instruments with the FDA for Pulse Lavage.
| Device ID | K854543 |
| 510k Number | K854543 |
| Device Name: | PULSE LAVAGE |
| Classification | Lavage, Jet |
| Applicant | TAVA SURGICAL INSTRUMENTS 7756 BURNETT AVE. Van Nuys, CA 91405 |
| Contact | Terry M Mattchen |
| Correspondent | Terry M Mattchen TAVA SURGICAL INSTRUMENTS 7756 BURNETT AVE. Van Nuys, CA 91405 |
| Product Code | FQH |
| CFR Regulation Number | 880.5475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-11-13 |
| Decision Date | 1986-01-27 |