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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Media, Reproductive
510(k) Number K192644
Device Name GM501 SpermAir and GM501 SpermActive
Applicant
Hamilton Thorne Incorporated
100 Cummings Center, Suite 465E
Beverly,  MA  01915
Applicant Contact Donald Fournier
Correspondent
Hamilton Thorne Incorporated
100 Cummings Center, Suite 465E
Beverly,  MA  01915
Correspondent Contact Donald Fournier
Regulation Number884.6180
Classification Product Code
MQL  
Date Received09/24/2019
Decision Date 04/23/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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