The following data is part of a premarket notification filed by Tri-med Specialties, Inc. with the FDA for Tri-med Endoscopic Fluid Introduction Catheter.
| Device ID | K931201 |
| 510k Number | K931201 |
| Device Name: | TRI-MED ENDOSCOPIC FLUID INTRODUCTION CATHETER |
| Classification | Endoscopic Irrigation/suction System |
| Applicant | TRI-MED SPECIALTIES, INC. P.O. BOX 23306 Overland Park, KS 66223 |
| Contact | Larry Scott |
| Correspondent | Larry Scott TRI-MED SPECIALTIES, INC. P.O. BOX 23306 Overland Park, KS 66223 |
| Product Code | OCX |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-03-09 |
| Decision Date | 1993-09-28 |