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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 K152723
Device Name Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices
Applicant
HOLOGIC, INC
250 CAMPUS DRIVE
MARLBOROUGH,  MA  01752
Applicant Contact CATHERINE EATON
Correspondent
HOLOGIC, INC
250 CAMPUS DRIVE
MARLBOROUGH,  MA  01752
Correspondent Contact CATHERINE EATON
Regulation Number884.1690
Classification Product Code
HIH  
Date Received09/22/2015
Decision Date 11/13/2015
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
Predetermined Change
Control Plan Authorized		 No
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