SaliPen
FDA 510(k) clearance K180838 · decided 2018-11-06
Clearance details
- K-number
- K180838
- Device name
- SaliPen
- Applicant
- Saliwell , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2018-03-30
- Decision date
- 2018-11-06
- Days to decision
- 221 days
- Clearance type
- Traditional
- Product code
- LTF
- Device class
- 2
- Regulation number
- 872.5560
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Harutzim, IL
- 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 |
|---|---|---|
| GenNarino (K160799) | Saliwell , Ltd. | 2017-02-17 |
Recalls involving this device
No recalls on record reference this clearance.