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FDA 510(k) Application Details - K212235
Device Classification Name
Mask, Surgical
More FDA Info for this Device
510(K) Number
K212235
Device Name
Mask, Surgical
Applicant
Shanghai Yunqing Industrial Co., Ltd.
2nd building 1818, Shangsu Road, Fengxian District
Shanghai 210000 CN
Other 510(k) Applications for this Company
Contact
Hulin No Last Name Provided
Other 510(k) Applications for this Contact
Regulation Number
878.4040
More FDA Info for this Regulation Number
Classification Product Code
FXX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/19/2021
Decision Date
12/06/2021
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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