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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nasopharyngoscope (Flexible Or Rigid)
510(k) Number K082667
Device Name VISIONSENSE STEREOSCOPIC VISION SYSTEM (VS SYSTEM)
Applicant
Visionsense, Ltd.
555 13th St., NW
Washington,  DC  20004
Applicant Contact GERARD J PRUD'HOMME
Correspondent
Visionsense, Ltd.
555 13th St., NW
Washington,  DC  20004
Correspondent Contact GERARD J PRUD'HOMME
Regulation Number874.4760
Classification Product Code
EOB  
Date Received09/12/2008
Decision Date 10/30/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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