PULMOSAL
Nebulizer (direct Patient Interface)
PHARMACARIBE
The following data is part of a premarket notification filed by Pharmacaribe with the FDA for Pulmosal.
Pre-market Notification Details
| Device ID | K130091 |
| 510k Number | K130091 |
| Device Name: | PULMOSAL |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-01-15 |
| Decision Date | 2013-03-13 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 60850877007037 | K130091 | 000 |
Trademark Results [PULMOSAL]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PULMOSAL 85682088 4308546 Live/Registered |
Pharmacaribe 2012-07-19 |
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