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FDA 510(k) Application Details - K161234
Device Classification Name
Instrument, Biopsy
More FDA Info for this Device
510(K) Number
K161234
Device Name
Instrument, Biopsy
Applicant
Scion Medical Technologies, LLC
4613 West Chester Pike
Newton Square, PA 19073 US
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Contact
Louis Li
Other 510(k) Applications for this Contact
Regulation Number
876.1075
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Classification Product Code
KNW
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More FDA Info for this Product Code
Date Received
05/02/2016
Decision Date
08/03/2016
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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