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FDA 510(k) Application Details - K123606
Device Classification Name
Instrument, Biopsy
More FDA Info for this Device
510(K) Number
K123606
Device Name
Instrument, Biopsy
Applicant
SCION MEDICAL TECHNOLOGIES LLC
23879 BLUE SPRUCE RD
SAUK CENTRE, MN 56378 US
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Contact
JOSEPH OSTENDORF
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
11/21/2012
Decision Date
03/01/2013
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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