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 |