FDA 510(k) Application Details - K143024

Device Classification Name Tracking, Soft Tissue, Intraoperative

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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
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Regulation Number 882.4560

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Classification Product Code OEW
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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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