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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Imaging, Pulsed Echo, Ultrasonic
510(k) Number K960765
Device Name MENTOR ADVENT A/B SYSTEM
Applicant
Mentor Ophthalmics, Inc.
3000 Longwater Dr.
Norwell,  MA  02061
Applicant Contact DAVID DOWNEY
Correspondent
Mentor Ophthalmics, Inc.
3000 Longwater Dr.
Norwell,  MA  02061
Correspondent Contact DAVID DOWNEY
Regulation Number892.1560
Classification Product Code
IYO  
Subsequent Product Code
ITX  
Date Received02/26/1996
Decision Date 08/08/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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