FDA 510(k) Application Details - K171534

Device Classification Name

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510(K) Number K171534
Device Name SurgicalPreview
Applicant Endo Vantage, LLC
1475 N Scottsdale Road, Suite 200
Scottsdale, AZ 85257 US
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Contact Robert S. Green
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Regulation Number

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Classification Product Code PZO
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Date Received 05/25/2017
Decision Date 11/08/2017
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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