Single-Use Surgical Mask With Ear Loop
FDA 510(k) clearance K201691 · decided 2020-09-17
Clearance details
- K-number
- K201691
- Device name
- Single-Use Surgical Mask With Ear Loop
- Applicant
- Qiqihar Hengxin Medical Supplies, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2020-06-22
- Decision date
- 2020-09-17
- Days to decision
- 87 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
- Qiqihar, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.