FDA 510(k) Application Details - K031173

Device Classification Name Guide, Needle, Surgical

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510(K) Number K031173
Device Name Guide, Needle, Surgical
Applicant NEEDLETECH PRODUCTS, INC.
81 WEST ST.
ATTLEBORO, MA 02703 US
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Contact RICK TRIPP
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Regulation Number 878.4800

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Classification Product Code GDF
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Date Received 04/14/2003
Decision Date 07/23/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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