FDA 510(k) Application Details - K211329

Device Classification Name Syringe, Antistick

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510(K) Number K211329
Device Name Syringe, Antistick
Applicant Jiangsu Kangbao Medical Equipment Co., Ltd
78#, North Suzhong Road, Baoying
Yangzhou 225800 CN
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Contact Rujun Tang
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Regulation Number 880.5860

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Classification Product Code MEG
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Date Received 05/03/2021
Decision Date 11/15/2021
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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