The following data is part of a premarket notification filed by Universal Medical Products, Inc. with the FDA for Dual Purpose Catheter.
| Device ID | K945994 |
| 510k Number | K945994 |
| Device Name: | DUAL PURPOSE CATHETER |
| Classification | Catheters, Suction, Tracheobronchial |
| Applicant | UNIVERSAL MEDICAL PRODUCTS, INC. 10 SCOTT ST. New Brunswick, NJ 08901 |
| Contact | Walter Jinotti |
| Correspondent | Walter Jinotti UNIVERSAL MEDICAL PRODUCTS, INC. 10 SCOTT ST. New Brunswick, NJ 08901 |
| Product Code | BSY |
| CFR Regulation Number | 868.6810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-22 |
| Decision Date | 1995-06-21 |