FDA 510(k) Application Details - K180983

Device Classification Name Container, Sharps

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510(K) Number K180983
Device Name Container, Sharps
Applicant Ningbo Maxcon Medical Technology Co., Ltd.
No.30 Dongbei Road/No.228 Dong Xin Road, Dong Qiao Town
Ningbo 315157 CN
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Contact Yang Song
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Regulation Number 880.5570

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Classification Product Code MMK
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Date Received 04/13/2018
Decision Date 01/03/2019
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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