The following data is part of a premarket notification filed by Automatic Liquid Packaging, Inc. with the FDA for Prefilled Respiratory Therapy Vials.
Device ID | K870332 |
510k Number | K870332 |
Device Name: | PREFILLED RESPIRATORY THERAPY VIALS |
Classification | Nebulizer, Medicinal, Non-ventilatory (atomizer) |
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 | CCQ |
CFR Regulation Number | 868.5640 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-01-28 |
Decision Date | 1987-04-01 |