FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Pasture F550S Surgical N95 Respirator, Pasture F550CS Surgical N95 Respirator, Pasture A520S Surgical N95 Respirator, Pasture A520CS Surgical N95 Respirator, Pasture E520S Surgical N95 Respirator, Pasture E520CS Surgical N95 Respirator
K Number: K141876
·
Decision Oct 28, 2015
Classifications
1
FEI Numbers
224
Registration Numbers
224
Same Product Code
34
Applicant Total
3
Review Days
474
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Basic Information
- Device Name
- Pasture F550S Surgical N95 Respirator, Pasture F550CS Surgical N95 Respirator, Pasture A520S Surgical N95 Respirator, Pasture A520CS Surgical N95 Respirator, Pasture E520S Surgical N95 Respirator, Pasture E520CS Surgical N95 Respirator
- K Number
- K141876
- 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
- Pasture Pharma Pte, Ltd.
- Date Received
- July 11, 2014
- Decision Date
- October 28, 2015
- 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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