FDA 510(k) Application Details - K160296

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

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510(K) Number K160296
Device Name Needle, Conduction, Anesthetic (W/Wo Introducer)
Applicant PAJUNK GMBH MEDIZINTECHNOLOGIE
KARL-HALL STR. 1
GEISINGEN 78187 DE
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Contact CHRISTIAN G.H. QUASS
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Regulation Number 868.5150

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Classification Product Code BSP
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Date Received 02/03/2016
Decision Date 10/27/2016
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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