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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 K131581
Device Name MYOSURE TISSUE REMOVAL DEVICE (1 PACK AND 3 PACK)
Applicant
HOLOGIC, INC.
250 CAMPUS DRIVE
MARLBOROUGH,  MA  01752
Applicant Contact SARAH FAIRFIELD
Correspondent
HOLOGIC, INC.
250 CAMPUS DRIVE
MARLBOROUGH,  MA  01752
Correspondent Contact SARAH FAIRFIELD
Regulation Number884.1690
Classification Product Code
HIH  
Date Received05/31/2013
Decision Date 08/22/2013
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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