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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name hysteroscope (and accessories)
510(k) Number K173901
Device Name MyoSure MANUAL Tissue Removal Device
Applicant
Hologic, Inc.
250 Campus Drive
Marlbrough,  MA  01752
Applicant Contact Anne-Marie Keefe
Correspondent
Hologic, Inc.
250 Campus Drive
Marlbrough,  MA  01752
Correspondent Contact Anne-Marie Keefe
Regulation Number884.1690
Classification Product Code
HIH  
Date Received12/22/2017
Decision Date 05/08/2018
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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