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 |