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 |