The following data is part of a premarket notification filed by Vygon Corp. with the FDA for Mucaid With Suction Catheter And Extension Tubing.
Device ID | K910908 |
510k Number | K910908 |
Device Name: | MUCAID WITH SUCTION CATHETER AND EXTENSION TUBING |
Classification | Catheters, Suction, Tracheobronchial |
Applicant | VYGON CORP. 227 BROADWAY SUITE 100 New York, NY 10007 |
Contact | Harry A Schlakman |
Correspondent | Harry A Schlakman VYGON CORP. 227 BROADWAY SUITE 100 New York, NY 10007 |
Product Code | BSY |
CFR Regulation Number | 868.6810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-03-05 |
Decision Date | 1991-05-20 |