510(k) K101532
- Device
- NESSI OTC SPACER
- Applicant
- PHARMACARIBE
- 510(k) number
- K101532
- Product code
- NVO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2010-09-01
- Date received
- 2010-06-03
- Regulation
- 868.5630
- Classification name
- Spacer, Direct Patient Interface
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- PAUL DRYDEN
- Address
- 24301 Woodsage Dr. Bonita Springs FL US 34134 34134
FDA Registration Numbers#
- 2028807
- 3031506335
- 8043316
- 3006500694
Source Documents#
Other 510(k) Records For Product Code NVO #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K091862 | NESSI SPACER | Pharmacaribe | 2009-11-20 |
Legacy Summary#
summary
FDA Review#
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