NESSI OTC SPACER
FDA 510(k) clearance K101532 · decided 2010-09-01
Clearance details
- K-number
- K101532
- Device name
- NESSI OTC SPACER
- Applicant
- Pharmacaribe
- Decision
- Substantially Equivalent
- Date received
- 2010-06-03
- Decision date
- 2010-09-01
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- NVO
- Device class
- 2
- Regulation number
- 868.5630
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Bonita Springs, FL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| NESSI SPACER (K091862) | Pharmacaribe | 2009-11-20 |
Recalls involving this device
No recalls on record reference this clearance.