NESSI SPACER
Spacer, Direct Patient Interface
PHARMACARIBE
The following data is part of a premarket notification filed by Pharmacaribe with the FDA for Nessi Spacer.
Pre-market Notification Details
| Device ID | K091862 |
| 510k Number | K091862 |
| Device Name: | NESSI SPACER |
| Classification | Spacer, 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 | NVO |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-06-23 |
| Decision Date | 2009-11-20 |
| Summary: | summary |
Trademark Results [NESSI SPACER]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 NESSI SPACER 77733868 3730923 Dead/Cancelled |
PharmaCaribe, LLC 2009-05-11 |
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