American-Made Surgical Mask
FDA 510(k) clearance K210101 · decided 2022-01-26
Clearance details
- K-number
- K210101
- Device name
- American-Made Surgical Mask
- Applicant
- Armbrust, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2021-01-14
- Decision date
- 2022-01-26
- Days to decision
- 377 days
- Clearance type
- Abbreviated
- Product code
- FXX
- Device class
- 2
- Regulation number
- 878.4040
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Pflugerville, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.