FDA 510(k) Application Details - K071886

Device Classification Name Wrap, Sterilization

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510(K) Number K071886
Device Name Wrap, Sterilization
Applicant SHANGHAI JIANZHONG MEDICAL PACKAGING CO., LTD.
1558-1-2101 SOUTH XIZANG ROAD
SHANGHAI 200011 CN
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Contact LONGFU SONG
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Regulation Number 880.6850

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Classification Product Code FRG
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Date Received 07/09/2007
Decision Date 12/27/2007
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party Y
Expedited Review



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