The following data is part of a premarket notification filed by Fiberoptic Sensor Technlogies, Inc. with the FDA for Fst Council Tip Foley Catheter.
| Device ID | K922776 |
| 510k Number | K922776 |
| Device Name: | FST COUNCIL TIP FOLEY CATHETER |
| Classification | Device, Cystometric, Hydraulic |
| Applicant | FIBEROPTIC SENSOR TECHNLOGIES, INC. 501 AVIS DR. Ann Arbor, MI 48108 |
| Contact | Michael D Colliver |
| Correspondent | Michael D Colliver FIBEROPTIC SENSOR TECHNLOGIES, INC. 501 AVIS DR. Ann Arbor, MI 48108 |
| Product Code | FEN |
| CFR Regulation Number | 876.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-06-09 |
| Decision Date | 1993-07-20 |