The following data is part of a premarket notification filed by Automatic Liquid Packaging, Inc. with the FDA for Adjustable Entrainment Nebulizer.
Device ID | K882936 |
510k Number | K882936 |
Device Name: | ADJUSTABLE ENTRAINMENT NEBULIZER |
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 | 1988-07-13 |
Decision Date | 1989-01-09 |