FDA 510(k) Application Details - K210222

Device Classification Name Mask, Surgical

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510(K) Number K210222
Device Name Mask, Surgical
Applicant Guangdong Lide Medical Technology Co., Ltd.
HFDB-05-2102 Ecological Technology City, West Side of Haizi
Road
Shanwei CN
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Contact Zhuang Shenglin
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Regulation Number 878.4040

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Classification Product Code FXX
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Date Received 01/28/2021
Decision Date 11/02/2021
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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