FDA 510(k) Application Details - K152952

Device Classification Name Catheter, Conduction, Anesthetic

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510(K) Number K152952
Device Name Catheter, Conduction, Anesthetic
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 868.5120

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Classification Product Code BSO
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Date Received 10/06/2015
Decision Date 07/13/2016
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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