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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 K121868
Device Name MYOSURE LITE TISSUE REMOVAL DEVICE (1 PACK), MYOSURE LITE TISSUE REMOVAL DEVICE (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 Received06/26/2012
Decision Date 07/19/2012
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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