The following data is part of a premarket notification filed by Icn Pharmaceuticals, Inc. with the FDA for Water Column Relief Valve.
| Device ID | K904398 |
| 510k Number | K904398 |
| Device Name: | WATER COLUMN RELIEF VALVE |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | ICN PHARMACEUTICALS, INC. ICN PLAZA 3300 HYLAND AVENUE Costa Mesa, CA 92626 |
| Contact | Alice Wei |
| Correspondent | Alice Wei ICN PHARMACEUTICALS, INC. ICN PLAZA 3300 HYLAND AVENUE Costa Mesa, CA 92626 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-09-25 |
| Decision Date | 1991-07-09 |