The following data is part of a premarket notification filed by The Ritedose Corporation with the FDA for Sodium Chloride Inhalation Solutions, 3%, 3.5%, 7% And 10%.
| Device ID | K210126 |
| 510k Number | K210126 |
| Device Name: | Sodium Chloride Inhalation Solutions, 3%, 3.5%, 7% And 10% |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | The Ritedose Corporation 1 Technology Circle Columbia, SC 29203 |
| Contact | Linda Valentine |
| Correspondent | Linda Valentine The Ritedose Corporation 1 Technology Circle Columbia, SC 29203 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-01-19 |
| Decision Date | 2021-12-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00376204023955 | K210126 | 000 |
| 00376204022958 | K210126 | 000 |
| 00376204021951 | K210126 | 000 |
| 00376204020954 | K210126 | 000 |