FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
3M High Performance Surgical Mask, 3M High Performance Surgical Mask with Face Shield
K Number: K180874
·
Decision Jul 31, 2018
Classifications
1
FEI Numbers
315
Registration Numbers
315
Same Product Code
606
Applicant Total
21
Review Days
119
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Basic Information
- Device Name
- 3M High Performance Surgical Mask, 3M High Performance Surgical Mask with Face Shield
- K Number
- K180874
- 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
- 3M Healthcare
- Date Received
- April 3, 2018
- Decision Date
- July 31, 2018
- 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 |
Similar 510(k) Clearances
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