FDA 510(k) Application Details - K142436

Device Classification Name Syringe, Antistick

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510(K) Number K142436
Device Name Syringe, Antistick
Applicant Sincere Medical Device Co., Ltd.
Rm 218, 2F., No.183, Zhouzi St.
Taipei City 114 TW
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Contact Garfield Wang
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Regulation Number 880.5860

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Classification Product Code MEG
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Date Received 08/29/2014
Decision Date 02/19/2015
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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