FDA 510(k) Application Details - K192914

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

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510(K) Number K192914
Device Name Needle, Conduction, Anesthetic (W/Wo Introducer)
Applicant Philips Medical Systems Nederland B.V.
Veenpluis 4-6
Best 5684 PC NL
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Contact Gert de Vries
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Regulation Number 868.5150

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Classification Product Code BSP
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Date Received 10/15/2019
Decision Date 05/27/2020
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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