The following data is part of a premarket notification filed by Automatic Liquid Packaging, Inc. with the FDA for Prefilled Respiratory Therapy Vial.
| Device ID | K830943 |
| 510k Number | K830943 |
| Device Name: | PREFILLED RESPIRATORY THERAPY VIAL |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | AUTOMATIC LIQUID PACKAGING, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-03-24 |
| Decision Date | 1983-04-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10190752196513 | K830943 | 000 |