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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 K100559
FOIA Releasable 510(k) K100559
Device Name MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM
Applicant
INTERLACE MEDICAL INC.
135 NEWBURY ST
FRAMINGHAM,  MA  01701
Applicant Contact John Vozella
Correspondent
INTERLACE MEDICAL INC.
135 NEWBURY ST
FRAMINGHAM,  MA  01701
Correspondent Contact John Vozella
Regulation Number884.1690
Classification Product Code
HIH  
Date Received03/01/2010
Decision Date 03/30/2010
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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