The following data is part of a premarket notification filed by Tri-state Hospital Supply Corp. with the FDA for Centurion Umbilical Catheter.
| Device ID | K942353 |
| 510k Number | K942353 |
| Device Name: | CENTURION UMBILICAL CATHETER |
| Classification | Catheter, Umbilical Artery |
| Applicant | TRI-STATE HOSPITAL SUPPLY CORP. 301 CATRELL DR. Howell, MI 48843 |
| Contact | George J Pluta |
| Correspondent | George J Pluta TRI-STATE HOSPITAL SUPPLY CORP. 301 CATRELL DR. Howell, MI 48843 |
| Product Code | FOS |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-05-17 |
| Decision Date | 1995-08-15 |