FDA 510(k) Application Details - K100665

Device Classification Name Syringe, Piston

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510(K) Number K100665
Device Name Syringe, Piston
Applicant NEEDLETECH PRODUCTS, INC.
81 WEST ST.
ATTLEBORO, MA 02703 US
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Contact RICK TRIPP
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Regulation Number 880.5860

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Classification Product Code FMF
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Date Received 03/08/2010
Decision Date 06/24/2010
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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