FirstSense Breast Exam— 510(k) K160573

Substantially Equivalent

First Sense Medical, LLC

FDA 510(k) clearance K160573 for FirstSense Breast Exam, Substantially Equivalent on 2016-06-01. Applicant: First Sense Medical, LLC.

Clearance details

Applicant: First Sense Medical, LLC
Product code: Code LHQ
Advisory panel: Obstetrics/Gynecology
Date received: 2016-02-29
Decision date: 2016-06-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pontiac, MI, US

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