The following data is part of a premarket notification filed by Vygon Corp. with the FDA for Vygon Lifevac Mid-line Tray.
| Device ID | K954112 |
| 510k Number | K954112 |
| Device Name: | VYGON LIFEVAC MID-LINE TRAY |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | VYGON CORP. 304 VERONA AVE. Elizabeth, NJ 07208 |
| Contact | Harry A Schlakman |
| Correspondent | Harry A Schlakman VYGON CORP. 304 VERONA AVE. Elizabeth, NJ 07208 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-07-31 |
| Decision Date | 1996-05-09 |