FDA 510(k) Application Details - K110421

Device Classification Name Syringe, Piston

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510(K) Number K110421
Device Name Syringe, Piston
Applicant WENZHOU WUZHOU IMPORT & EXPORT CO., LTD
P.O. BOX 237-023
BINGYI XIANG, ZHEJIANG 325000 CN
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Contact Diana Hong
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Regulation Number 880.5860

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Classification Product Code FMF
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Date Received 02/14/2011
Decision Date 04/26/2011
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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