Durio Surgical Face Mask, Models 501 (3-ply, blue) and 545 (4-ply,blue)
FDA 510(k) clearance K230395 · decided 2023-07-17
Clearance details
- K-number
- K230395
- Device name
- Durio Surgical Face Mask, Models 501 (3-ply, blue) and 545 (4-ply,blue)
- Applicant
- Durio Ppe Sdn Bhd
- Decision
- Substantially Equivalent
- Date received
- 2023-02-14
- Decision date
- 2023-07-17
- Days to decision
- 153 days
- Clearance type
- Traditional
- Product code
- FXX
- Device class
- 2
- Regulation number
- 878.4040
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Johor Bahru, MY
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.