GM501 SpermAir And GM501 SpermActive

Media, Reproductive

Hamilton Thorne Incorporated

The following data is part of a premarket notification filed by Hamilton Thorne Incorporated with the FDA for Gm501 Spermair And Gm501 Spermactive.

Pre-market Notification Details

Device IDK192644
510k NumberK192644
Device Name:GM501 SpermAir And GM501 SpermActive
ClassificationMedia, Reproductive
Applicant Hamilton Thorne Incorporated 100 Cummings Center, Suite 465E Beverly,  MA  01915
ContactDonald Fournier
CorrespondentDonald Fournier
Hamilton Thorne Incorporated 100 Cummings Center, Suite 465E Beverly,  MA  01915
Product CodeMQL  
CFR Regulation Number884.6180 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-09-24
Decision Date2020-04-23

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