FDA 510(k) Application Details - K062173

Device Classification Name Syringe, Piston

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510(K) Number K062173
Device Name Syringe, Piston
Applicant WRIGHT MEDICAL TECHNOLOGY, INC.
5677 AIRLINE RD.
ARLINGTON, TN 38002 US
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Contact WESLEY L REED
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Regulation Number 880.5860

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Classification Product Code FMF
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Date Received 07/31/2006
Decision Date 08/23/2006
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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