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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Culdoscope (And Accessories)
510(k) Number K111014
Device Name LSI SOLUTIONS FORNISEE SYSTEM UTERINE MANIPULATOR AND ACCESSORIES
Applicant
Lsi Solutions, Inc.
7796 Victor-Mendon Rd.
Victor,  NY  14564
Applicant Contact JUDE S SAUER, M.D.
Correspondent
Lsi Solutions, Inc.
7796 Victor-Mendon Rd.
Victor,  NY  14564
Correspondent Contact JUDE S SAUER, M.D.
Regulation Number884.1640
Classification Product Code
HEW  
Subsequent Product Code
LKF  
Date Received04/11/2011
Decision Date 07/13/2012
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
Predetermined Change
Control Plan Authorized		 No
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