FDA 510(k) Application Details - K090131

Device Classification Name Respirator,Surgical

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510(K) Number K090131
Device Name Respirator,Surgical
Applicant SHANGHAI DASHENG HEALTH PRODUCTS
SONGJIANG DISTRICT
SHANGHAI CN
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Contact MAGGIE ZHONG
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Regulation Number 878.4040

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Classification Product Code MSH
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Date Received 01/21/2009
Decision Date 04/27/2009
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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