The following data is part of a premarket notification filed by Sherwood Medical Co. with the FDA for Argyle Neo-sert Hydrophilic Polyurethane Umbilical Vessel Catheter Insertion Tray.
| Device ID | K954300 |
| 510k Number | K954300 |
| Device Name: | ARGYLE NEO-SERT HYDROPHILIC POLYURETHANE UMBILICAL VESSEL CATHETER INSERTION TRAY |
| Classification | Catheter, Umbilical Artery |
| Applicant | SHERWOOD MEDICAL CO. 1915 OLIVE ST. St. Louis, MO 63103 -1625 |
| Contact | Dennis Pozzo |
| Correspondent | Dennis Pozzo SHERWOOD MEDICAL CO. 1915 OLIVE ST. St. Louis, MO 63103 -1625 |
| Product Code | FOS |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-09-14 |
| Decision Date | 1995-12-13 |