GM501 SpermAir and GM501 SpermActive— 510(k) K192644

Substantially Equivalent

Hamilton Thorne Incorporated

FDA 510(k) clearance K192644 for GM501 SpermAir and GM501 SpermActive, Substantially Equivalent on 2020-04-23. Applicant: Hamilton Thorne Incorporated.

Clearance details

Applicant
Hamilton Thorne Incorporated
Product code
Code MQL
Advisory panel
Obstetrics/Gynecology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Beverly, MA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.