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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
Model 30-401, 30-403
Device Name MYOSURE LITE TISSUE REMOVAL DEVICE (1 PACK), MYOSURE LITE TISSUE REMOVAL DEVICE (3 PACK)
Original Applicant
HOLOGIC, INC.
250 campus drive
marlborough,  MA  01752
Original Contact sarah fairfield
Regulation Number884.1690
Classification Product Code
HIH  
Date Received06/26/2012
Decision Date 07/19/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Obstetrics/Gynecology
Review Advisory Committee Obstetrics/Gynecology
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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