FDA 510(k) Application Details - K060211

Device Classification Name Syringe, Piston

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510(K) Number K060211
Device Name Syringe, Piston
Applicant WENZHOU WUZHOU GROUP CO. LTD.
1800 CENTURY PARK EAST
SUITE 600
LOS ANGELES, CA 90067 US
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Contact GEORGE SU
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Regulation Number 880.5860

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Classification Product Code FMF
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Date Received 01/27/2006
Decision Date 02/10/2006
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 Y
Expedited Review



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