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FDA 510(k) Application Details - K063697
Device Classification Name
Instrument, Biopsy
More FDA Info for this Device
510(K) Number
K063697
Device Name
Instrument, Biopsy
Applicant
PAJUNK GMBH MEDIZINTECHNOLOGIE
KARL-HALL-STRASSE 1
GEISINGEN, BADEN-WURTTEMBERG 78187 DE
Other 510(k) Applications for this Company
Contact
CHRISTIAN QUASS
Other 510(k) Applications for this Contact
Regulation Number
876.1075
More FDA Info for this Regulation Number
Classification Product Code
KNW
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/13/2006
Decision Date
02/14/2007
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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