SaliPen— 510(k) K180838
Substantially EquivalentSaliwell , Ltd.
FDA 510(k) clearance K180838 for SaliPen, Substantially Equivalent on 2018-11-06. Applicant: Saliwell , Ltd.. Device class: 2.
Clearance details
- Applicant
- Saliwell , Ltd.
- Product code
- Code LTF
- Device class
- Class 2
- Regulation
- 21 CFR 872.5560
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Harutzim, IL
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