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 |