The following data is part of a premarket notification filed by Temporaty Surgical Systems with the FDA for X-vee.
| Device ID | K810152 |
| 510k Number | K810152 |
| Device Name: | X-VEE |
| Classification | Instrument, Vitreous Aspiration And Cutting, Battery-powered |
| Applicant | TEMPORATY SURGICAL SYSTEMS 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | HKP |
| CFR Regulation Number | 886.4150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-01-21 |
| Decision Date | 1981-03-17 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() X-VEE 73312900 1222486 Dead/Cancelled |
Contemporary Surgical Systems, Inc. 1981-06-02 |