Sentinel BreastScan II System— 510(k) K162767

Substantially Equivalent

First Sense Medical, LLC

FDA 510(k) clearance K162767 for Sentinel BreastScan II System, Substantially Equivalent on 2017-01-09. Applicant: First Sense Medical, LLC.

Clearance details

Applicant: First Sense Medical, LLC
Product code: Code LHQ
Advisory panel: Obstetrics/Gynecology
Date received: 2016-09-30
Decision date: 2017-01-09
Decision: Substantially Equivalent
Clearance type: Special
Location: Pontiac, MI, US

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