FDA 510(k) Application Details - K150956

Device Classification Name Laparoscope, General & Plastic Surgery

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510(K) Number K150956
Device Name Laparoscope, General & Plastic Surgery
Applicant NOVADAQ TECHNOLOGIES, INC.
8329 Eastlake Drive, Unit 101
Burnaby V5A4W2 CA
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Contact TIM VERSPAGEN
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Regulation Number 876.1500

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Classification Product Code GCJ
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Date Received 04/09/2015
Decision Date 05/23/2016
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
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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