The following data is part of a premarket notification filed by Automatic Liquid Packaging, Inc. with the FDA for Sterile Water Or O.9% Sodium Chloride, Model Al4100 & Al4109.
| Device ID | K000964 |
| 510k Number | K000964 |
| Device Name: | STERILE WATER OR O.9% SODIUM CHLORIDE, MODEL AL4100 & AL4109 |
| Classification | Tube Tracheostomy And Tube Cuff |
| Applicant | AUTOMATIC LIQUID PACKAGING, INC. 2200 LAKE SHORE DR. Woodstock, IL 60098 |
| Contact | John Brda |
| Correspondent | John Brda AUTOMATIC LIQUID PACKAGING, INC. 2200 LAKE SHORE DR. Woodstock, IL 60098 |
| Product Code | JOH |
| CFR Regulation Number | 868.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-03-27 |
| Decision Date | 2000-04-25 |