The following data is part of a premarket notification filed by Automatic Liquid Packaging, Inc. with the FDA for Prefilled Sodium Chloride Solution For Irriga. Usp.
| Device ID | K880317 |
| 510k Number | K880317 |
| Device Name: | PREFILLED SODIUM CHLORIDE SOLUTION FOR IRRIGA. USP |
| Classification | Tube, Tracheostomy (w/wo Connector) |
| 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 | BTO |
| CFR Regulation Number | 868.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-01-26 |
| Decision Date | 1988-02-29 |