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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 K051851
Device Name AVISO OPHTHALMIC ULTRASOUND SYSTEM
Applicant
QUANTEL MEDICAL
377 ROUTE 17 SOUTH
HASBROUCK HEIGHTS,  NJ  07604
Applicant Contact GEORGE MYERS
Correspondent
QUANTEL MEDICAL
377 ROUTE 17 SOUTH
HASBROUCK HEIGHTS,  NJ  07604
Correspondent Contact GEORGE MYERS
Regulation Number892.1560
Classification Product Code
IYO  
Subsequent Product Code
ITX  
Date Received07/08/2005
Decision Date 08/03/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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