FDA 510(k) Application Details - K211890

Device Classification Name Container, Sharps

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510(K) Number K211890
Device Name Container, Sharps
Applicant Promisemed Hangzhou Meditech Co., Ltd.
No. 1388 Cangxing Street, Cangqian Community,Yuhang District
Hangzhou City 311121 CN
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Contact Zearou Yang
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Regulation Number 880.5570

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Classification Product Code MMK
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Date Received 06/21/2021
Decision Date 11/17/2021
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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