FDA 510(k) Application Details - K002405

Device Classification Name Needle, Conduction, Anesthetic (W/Wo Introducer)

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510(K) Number K002405
Device Name Needle, Conduction, Anesthetic (W/Wo Introducer)
Applicant TE ME NA S.A.R.L.
3234 ELLA LN.
NEW PORT RICHEY, FL 34655 US
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Contact ART WARD
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Regulation Number 868.5150

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Classification Product Code BSP
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Date Received 08/07/2000
Decision Date 06/01/2001
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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