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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 doppler, ultrasonic
510(k) Number K100989
Device Name ZURA TEE SYSTEM WITH CLARITEE PROBE
Applicant
IMACOR INC.
50 CHARLES LINDBERGH BLVD
SUITE 200
uniondale,  NY  11553
Applicant Contact richard lanzillotto
Correspondent
IMACOR INC.
50 CHARLES LINDBERGH BLVD
SUITE 200
uniondale,  NY  11553
Correspondent Contact richard lanzillotto
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received04/09/2010
Decision Date 06/25/2010
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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