510(k) K203534
K203534 is an FDA 510(k) premarket notification submitted by Crown Name Disposable Hygiene Products Fty., Ltd. for the device "Surgical face mask (Model: Flat Ear Loop/CN102)". The FDA issued a decision of Substantially Equivalent on July 21, 2021. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040. Crown Name Disposable Hygiene Products Fty., Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 21, 2021
- Date Received
- December 2, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mask, Surgical
- Device Class
- Class II
- Regulation Number
- 878.4040
- Review Panel
- HO
- Submission Type