The following data is part of a premarket notification filed by Surgeon Surgical Instrumentation, Inc. with the FDA for Uni-port.
| Device ID | K880543 |
| 510k Number | K880543 |
| Device Name: | UNI-PORT |
| Classification | Device, Irrigation, Ocular Surgery |
| Applicant | SURGEON SURGICAL INSTRUMENTATION, INC. 1030 RICHFIELD RD. Placentia, CA 92670 |
| Contact | Stephen M Priolo |
| Correspondent | Stephen M Priolo SURGEON SURGICAL INSTRUMENTATION, INC. 1030 RICHFIELD RD. Placentia, CA 92670 |
| Product Code | KYG |
| CFR Regulation Number | 886.4360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-02-09 |
| Decision Date | 1988-07-01 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() UNI-PORT 75793295 2362338 Dead/Cancelled |
Staubli International AG 1999-09-07 |