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FDA 510(k) Applications Submitted by Donald Fournier
FDA 510(k) Number
Submission Date
Device Name
Applicant
K190383
02/19/2019
GM501 Wash
Hamilton Thorne, Inc.
K191552
06/12/2019
GM501 Mineral Oil
Hamilton Thorne Inc.
K202241
08/10/2020
LYKOS Assisted Reproduction Laser with Dynamic Targeting System (DTS)
Hamilton Thorne, Inc.
K192503
09/12/2019
GM501 Wash with Phenol Red and Gentamicin
Hamilton Thorne Incorporated
K192644
09/24/2019
GM501 SpermAir and GM501 SpermActive
Hamilton Thorne Incorporated
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