The following data is part of a premarket notification filed by Vygon Corp. with the FDA for Vygon Umbilical Cathether Insertion Tray.
| Device ID | K963196 |
| 510k Number | K963196 |
| Device Name: | VYGON UMBILICAL CATHETHER INSERTION TRAY |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | VYGON CORP. ONE MADISON ST. East Rutherford, NJ 07073 |
| Contact | Anne Marie Cesario |
| Correspondent | Anne Marie Cesario VYGON CORP. ONE MADISON ST. East Rutherford, NJ 07073 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-08-15 |
| Decision Date | 1997-09-09 |