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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 K190383
Device Name GM501 Wash
Applicant
Hamilton Thorne, Inc.
100 Cummings Center, Suite 465E
Beverly,  MA  01915
Applicant Contact Donald Fournier
Correspondent
Hamilton Thorne, Inc.
100 Cummings Center, Suite 465E
Beverly,  MA  01915
Correspondent Contact Donald Fournier
Regulation Number884.6180
Classification Product Code
MQL  
Date Received02/19/2019
Decision Date 09/05/2019
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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