The following data is part of a premarket notification filed by Cypress Medical Products, Ltd. with the FDA for Cypress Medical Products Catheter (insertion) Tray.
| Device ID | K950092 |
| 510k Number | K950092 |
| Device Name: | CYPRESS MEDICAL PRODUCTS CATHETER (INSERTION) TRAY |
| Classification | Tray, Catheterization, Sterile Urethral, With Or Without Catheter (kit) |
| Applicant | CYPRESS MEDICAL PRODUCTS, LTD. 1202 SOUTH ROUTE 31 Mchenry, IL 60050 |
| Contact | Ken Rysso |
| Correspondent | Ken Rysso CYPRESS MEDICAL PRODUCTS, LTD. 1202 SOUTH ROUTE 31 Mchenry, IL 60050 |
| Product Code | FCM |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-01-10 |
| Decision Date | 1995-02-27 |