The following data is part of a premarket notification filed by Automatic Liquid Packaging, Inc. with the FDA for Ster Inhal Solut Prefil Btl W/adjust Entrain Nebul.
| Device ID | K901301 |
| 510k Number | K901301 |
| Device Name: | STER INHAL SOLUT PREFIL BTL W/ADJUST ENTRAIN NEBUL |
| 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 | 1990-03-20 |
| Decision Date | 1990-05-31 |