Surgical Mask (Procedure Mask) (Models: OH02-01, OH02-01 (Bandage))
FDA 510(k) clearance K203418 · decided 2021-09-17
Clearance details
- K-number
- K203418
- Device name
- Surgical Mask (Procedure Mask) (Models: OH02-01, OH02-01 (Bandage))
- Applicant
- Ningbo Ouhan Medical Device Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2020-11-19
- Decision date
- 2021-09-17
- Days to decision
- 302 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
- Yuyao City, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.