FDA 510(k) Application Details - K221073

Device Classification Name Syringe, Antistick

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510(K) Number K221073
Device Name Syringe, Antistick
Applicant Sichuan Prius Biotechnology Co., Ltd.
No.2 Prius Road, Luo Long Industrial Park Nanxi District
Yibin 644104 CN
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Contact Yan Liu
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Regulation Number 880.5860

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Classification Product Code MEG
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Date Received 04/12/2022
Decision Date 10/04/2022
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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