FDA 510(k)
FDA class 2
Substantially Equivalent
🇯🇵 Japan
ROKI Surgical Mask
K Number: K214094
·
Decision Feb 24, 2022
Classifications
1
FEI Numbers
315
Registration Numbers
315
Same Product Code
606
Applicant Total
1
Review Days
58
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Basic Information
- Device Name
- ROKI Surgical Mask
- K Number
- K214094
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4040
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Roki Co., Ltd.
- Date Received
- December 28, 2021
- Decision Date
- February 24, 2022
- Product Code
- FXX
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| FXX | Mask, Surgical | FDA class 2 | General, Plastic Surgery |
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