FDA 510(k) Application Details - K210229

Device Classification Name Syringe, Antistick

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510(K) Number K210229
Device Name Syringe, Antistick
Applicant Zhejiang Kangkang Medical-Devices CO., Ltd.
Longwang Industrial District, Chumen Town
Yuhuan 317605 CN
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Contact Chun Guo
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Regulation Number 880.5860

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Classification Product Code MEG
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Date Received 01/28/2021
Decision Date 02/15/2022
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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