FDA 510(k) Application Details - K201523

Device Classification Name Container, Sharps

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510(K) Number K201523
Device Name Container, Sharps
Applicant Zhejiang Gongdong Medical Technology Co., Ltd
No.10, Beiyuan Avenue, Huangyan
Taizhou 318020 CN
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Contact Weifeng Zhong
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Regulation Number 880.5570

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Classification Product Code MMK
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Date Received 06/08/2020
Decision Date 11/12/2020
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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