Identifiers
- 510(k) Number
- K141875 FDA 510(k)
- FDA Product Code
- FXX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4040 FDA 510(k)
- Regulation Number
- 878.4040 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
A comprehensive surgical mask designed for general, plastic surgery procedures, available in the US market. This device has been substantially equivalent to other similar masks and is subject to certain regulatory requirements.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K141875 | Class II | Active |
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Manufacturer
- Manufacturer
- Pasture Pharma Pte, Ltd.
Sources (1)
- FDA 510(k) K141875 24 fields · synced Jul 10, 2026