FDA 510(k)
FDA class 1
Substantially Equivalent
🇰🇷 South Korea
SMARTO
K Number: K163308
·
Decision Dec 27, 2016
Classifications
1
FEI Numbers
81
Registration Numbers
81
Same Product Code
28
Applicant Total
53
Review Days
34
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Basic Information
- Device Name
- SMARTO
- K Number
- K163308
- Device Class
- FDA class 1
- Clearance Type
- Special
- Regulation Number
- 878.4820
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Jeil Medical Corporation
- Date Received
- November 23, 2016
- Decision Date
- December 27, 2016
- Product Code
- KIJ
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KIJ | Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment | FDA class 1 | General, Plastic Surgery |
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