FDA 510(k) Application Details - K063233

Device Classification Name Instrument, Biopsy

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510(K) Number K063233
Device Name Instrument, Biopsy
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 876.1075

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Classification Product Code KNW
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Date Received 10/25/2006
Decision Date 04/30/2007
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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