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FDA 510(k) Application Details - K070179
Device Classification Name
Kit, Needle, Biopsy
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
876.1075
More FDA Info for this Regulation Number
Classification Product Code
FCG
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More FDA Info for this Product Code
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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