N95 Particulate Respirator and Surgical Mask, Models TN01-11 and TN01-12— 510(k) K160271
Substantially EquivalentSan-M Package Co., Ltd.
FDA 510(k) clearance K160271 for N95 Particulate Respirator and Surgical Mask, Models TN01-11 and TN01-12, Substantially Equivalent on 2016-07-15. Applicant: San-M Package Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- San-M Package Co., Ltd.
- Product code
- Code MSH
- Device class
- Class 2
- Regulation
- 21 CFR 878.4040
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Shimada-City, JP
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