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FDA 510(k) Application Details - K143024
Device Classification Name
Tracking, Soft Tissue, Intraoperative
More FDA Info for this Device
510(K) Number
K143024
Device Name
Tracking, Soft Tissue, Intraoperative
Applicant
CAScination AG
Stauffacherstrasse 78
Bern 3014 CH
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Contact
Matthias Peterhans
Other 510(k) Applications for this Contact
Regulation Number
882.4560
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Classification Product Code
OEW
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More FDA Info for this Product Code
Date Received
10/21/2014
Decision Date
04/28/2015
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
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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