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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name interventional fluoroscopic x-ray system
510(k) Number K120282
Device Name CARDNAV
Applicant
PAIEON, INC.
23 HAMELACHA ST., P.O.B. 11355
ROSH HAAYIN,  IL 48901
Applicant Contact SHIMON VAKNIN
Correspondent
PAIEON, INC.
23 HAMELACHA ST., P.O.B. 11355
ROSH HAAYIN,  IL 48901
Correspondent Contact SHIMON VAKNIN
Regulation Number892.1650
Classification Product Code
OWB  
Subsequent Product Code
LLZ  
Date Received01/31/2012
Decision Date 12/10/2012
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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