FDA 510(k)
FDA class 2
Substantially Equivalent
🇯🇵 Japan
N95 Particulate Respirator and Surgical Mask, Models TN01-11 and TN01-12
K Number: K160271
·
Decision Jul 15, 2016
Classifications
1
FEI Numbers
224
Registration Numbers
224
Same Product Code
34
Applicant Total
3
Review Days
164
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Basic Information
- Device Name
- N95 Particulate Respirator and Surgical Mask, Models TN01-11 and TN01-12
- K Number
- K160271
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 878.4040
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- San-M Package Co., Ltd.
- Date Received
- February 2, 2016
- Decision Date
- July 15, 2016
- Product Code
- MSH
- 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 |
|---|---|---|---|
| MSH | Respirator, Surgical | FDA class 2 | General, Plastic Surgery |
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