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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 K091465
Device Name MYOSURE ROD LENS HYSTEROSCOPE
Applicant
INTERLACE MEDICAL, INC.
135 NEWBURY STREET
FRAMINGHAM,  MA  01701
Applicant Contact John Vozella
Correspondent
INTERLACE MEDICAL, INC.
135 NEWBURY STREET
FRAMINGHAM,  MA  01701
Correspondent Contact John Vozella
Regulation Number884.1690
Classification Product Code
HIH  
Date Received05/18/2009
Decision Date 08/21/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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