FDA 510(k) Application Details - K070179

Device Classification Name Kit, Needle, Biopsy

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510(K) Number K070179
Device Name Kit, Needle, Biopsy
Applicant PAJUNK GMBH MEDIZINTECHNOLOGIE
KARL-HALL-STRASSE 1
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 FCG
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Date Received 01/19/2007
Decision Date 03/07/2007
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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