The following data is part of a premarket notification filed by Pharmacaribe with the FDA for Pharmacaribe Inhaled Saline Solutions.
| Device ID | K101424 |
| 510k Number | K101424 |
| Device Name: | PHARMACARIBE INHALED SALINE SOLUTIONS |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | PHARMACARIBE 24301 WOODSAGE DRIVE Bonita Springs, FL 34134 |
| Contact | Paul Dryden |
| Correspondent | Paul Dryden PHARMACARIBE 24301 WOODSAGE DRIVE Bonita Springs, FL 34134 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-05-20 |
| Decision Date | 2010-08-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 40850877007026 | K101424 | 000 |
| 60850877007013 | K101424 | 000 |
| 60850877007006 | K101424 | 000 |