The following data is part of a premarket notification filed by Automatic Liquid Packaging, Inc. with the FDA for Sterile Water And 0.9% Sodium Chloride For Irrigation, Usp.
| Device ID | K994321 |
| 510k Number | K994321 |
| Device Name: | STERILE WATER AND 0.9% SODIUM CHLORIDE FOR IRRIGATION, USP |
| Classification | Catheter And Tip, Suction |
| 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 | JOL |
| CFR Regulation Number | 880.6740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-12-22 |
| Decision Date | 2000-10-25 |
| Summary: | summary |