FDA 510(k) Application Details - K052667

Device Classification Name Syringe, Piston

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510(K) Number K052667
Device Name Syringe, Piston
Applicant ARTSANA S.P.A.
22411 60TH STREET
BRISTOL, WI 53104 US
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Contact LARA N SIMMONS
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Regulation Number 880.5860

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Classification Product Code FMF
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Date Received 09/27/2005
Decision Date 11/25/2005
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Statement
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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