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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 K172566
Device Name Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices
Applicant
Hologic, Inc.
250 Campus Drive
Marlborough,  MA  01752
Applicant Contact Catherine Sanford
Correspondent
Hologic, Inc.
250 Campus Drive
Marlborough,  MA  01752
Correspondent Contact Catherine Sanford
Regulation Number884.1690
Classification Product Code
HIH  
Date Received08/25/2017
Decision Date 09/20/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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