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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 K102686
Device Name MYOSURE ROD LENS SCOPE SEALS
Applicant
Interlace Medical, Inc.
139 Newbury St.
Framingham,  MA  01701
Applicant Contact JOHN J VOZELLA
Correspondent
Interlace Medical, Inc.
139 Newbury St.
Framingham,  MA  01701
Correspondent Contact JOHN J VOZELLA
Regulation Number884.1690
Classification Product Code
HIH  
Date Received09/17/2010
Decision Date 10/15/2010
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
Predetermined Change
Control Plan Authorized		 No
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