FDA 510(k) Application Details - K080675

Device Classification Name Catheter, Conduction, Anesthetic

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510(K) Number K080675
Device Name Catheter, Conduction, Anesthetic
Applicant PAJUNK GMBH MEDIZINTECHNOLOGIE
KARL-HALL-STRASSE 01
GEISINGEN, BADEN-WURTTEMBERG 78187 DE
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Contact CHRISTIAN QUASS
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Regulation Number 868.5120

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Classification Product Code BSO
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Date Received 03/10/2008
Decision Date 06/20/2008
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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