The following data is part of a premarket notification filed by Automatic Liquid Packaging, Inc. with the FDA for Accessory Fitment To Nebulizer System, Sterile.
Device ID | K901362 |
510k Number | K901362 |
Device Name: | ACCESSORY FITMENT TO NEBULIZER SYSTEM, STERILE |
Classification | Nebulizer (direct Patient Interface) |
Applicant | AUTOMATIC LIQUID PACKAGING, INC. 2200 W. LAKE SHORE DR. Woodstock, IL 60098 |
Contact | Frank Leo |
Correspondent | Frank Leo AUTOMATIC LIQUID PACKAGING, INC. 2200 W. LAKE SHORE DR. Woodstock, IL 60098 |
Product Code | CAF |
CFR Regulation Number | 868.5630 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-03-23 |
Decision Date | 1990-06-06 |