The following data is part of a premarket notification filed by Automatic Liquid Packaging, Inc. with the FDA for Irrigation Bottle.
| Device ID | K973829 |
| 510k Number | K973829 |
| Device Name: | IRRIGATION BOTTLE |
| Classification | Tube Tracheostomy And Tube Cuff |
| Applicant | AUTOMATIC LIQUID PACKAGING, INC. 2200 W. LAKE SHORE DR. Woodstock, IL 60098 |
| Contact | John Brda |
| Correspondent | John Brda AUTOMATIC LIQUID PACKAGING, INC. 2200 W. LAKE SHORE DR. Woodstock, IL 60098 |
| Product Code | JOH |
| CFR Regulation Number | 868.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-10-07 |
| Decision Date | 1998-02-23 |
| Summary: | summary |