The following data is part of a premarket notification filed by Pharmacaribe with the FDA for Nessi Otc Spacer.
| Device ID | K101532 |
| 510k Number | K101532 |
| Device Name: | NESSI OTC 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 | 2010-06-03 |
| Decision Date | 2010-09-01 |
| Summary: | summary |