The following data is part of a premarket notification filed by Vygon Corp. with the FDA for Dualyse-cath - Codes #1132.212, 1132.112.
| Device ID | K896568 |
| 510k Number | K896568 |
| Device Name: | DUALYSE-CATH - CODES #1132.212, 1132.112 |
| Classification | Catheter, Subclavian |
| Applicant | VYGON CORP. 277 BROADWAY SUITE #100 New York, NY 10007 |
| Contact | Harry A Schlakman |
| Correspondent | Harry A Schlakman VYGON CORP. 277 BROADWAY SUITE #100 New York, NY 10007 |
| Product Code | LFJ |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-11-20 |
| Decision Date | 1990-05-09 |