FDA 510(k) Application Details - K220204

Device Classification Name Syringe, Piston

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510(K) Number K220204
Device Name Syringe, Piston
Applicant Anhui Tiankang Medical Technology Co., Ltd.
No.228,Weiyi Road, Economic Development Zone,Tianchang City,
Anhui,China.
Tianchang 239300 CN
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Contact Zhang Yong
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Regulation Number 880.5860

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Classification Product Code FMF
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Date Received 01/25/2022
Decision Date 07/14/2022
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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