The following data is part of a premarket notification filed by Tava Surgical Instruments with the FDA for Tava Wire-driver.
| Device ID | K935367 |
| 510k Number | K935367 |
| Device Name: | TAVA WIRE-DRIVER |
| Classification | Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/attachment |
| Applicant | TAVA SURGICAL INSTRUMENTS 1715 SURVEYOR AVE. Simi Valley, CA 93063 |
| Contact | David Vanderhorst |
| Correspondent | David Vanderhorst TAVA SURGICAL INSTRUMENTS 1715 SURVEYOR AVE. Simi Valley, CA 93063 |
| Product Code | HSZ |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-11-04 |
| Decision Date | 1994-04-21 |