FDA 510(k) Application Details - K080674

Device Classification Name Device, Percutaneous, Biopsy

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510(K) Number K080674
Device Name Device, Percutaneous, 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 878.4800

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Classification Product Code MJG
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Date Received 03/10/2008
Decision Date 05/09/2008
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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