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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transducer, Ultrasonic
510(k) Number K111416
Device Name FALCON
Applicant
Viasonix , Ltd.
1 Odell Plz.
Yonkers,  NY  10701
Applicant Contact WILLIAM STERN
Correspondent
Viasonix , Ltd.
1 Odell Plz.
Yonkers,  NY  10701
Correspondent Contact WILLIAM STERN
Regulation Number870.2880
Classification Product Code
JOP  
Date Received05/20/2011
Decision Date 07/15/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
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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