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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 K140041
Device Name ZEN-7000,SYSTEM,FLUROSCOPIC X-RAY SYSTEM
Applicant
GENORAY CO., LTD.
3002 DOW AVENUE SUITE 420
TUSTIN,  CA  92780
Applicant Contact KAITLYNN MIN
Correspondent
GENORAY CO., LTD.
3002 DOW AVENUE SUITE 420
TUSTIN,  CA  92780
Correspondent Contact KAITLYNN MIN
Regulation Number892.1650
Classification Product Code
OWB  
Subsequent Product Codes
JAA   OXO  
Date Received01/08/2014
Decision Date 11/28/2014
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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