FDA 510(k) Application Details - K210464

Device Classification Name Syringe, Piston

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510(K) Number K210464
Device Name Syringe, Piston
Applicant Anhui Tiankang Medical Technology Co.,Ltd.
No.228 Weiyi Road, Economic Development Zone
Tianchang 239300 CN
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Contact Bai Baodong
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Regulation Number 880.5860

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Classification Product Code FMF
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Date Received 02/16/2021
Decision Date 08/24/2021
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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