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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 K073690
FOIA Releasable 510(k) K073690
Device Name INTERLACE MEDICAL HYSTEROSCOPIC MORCELLATION SYSTEM
Applicant
INTERLACE MEDICAL, INC.
139 NEWBURY STREET
FRAMINGHAM,  MA  01701
Applicant Contact RON ADAMS
Correspondent
INTERLACE MEDICAL, INC.
139 NEWBURY STREET
FRAMINGHAM,  MA  01701
Correspondent Contact RON ADAMS
Regulation Number884.1690
Classification Product Code
HIH  
Date Received12/28/2007
Decision Date 04/17/2008
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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