KEGEL SMART, KEGELSMART PEARL— 510(k) K140780

Substantially Equivalent

Regulatory Insight, Inc.

FDA 510(k) clearance K140780 for KEGEL SMART, KEGELSMART PEARL, Substantially Equivalent on 2014-09-10. Applicant: Regulatory Insight, Inc..

Clearance details

Applicant: Regulatory Insight, Inc.
Product code: Code HIR
Advisory panel: Obstetrics/Gynecology
Date received: 2014-03-28
Decision date: 2014-09-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Littleton, CO, US

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