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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, x-ray, fluoroscopic, image-intensified
510(k) Number K883161
Device Name HIMOBILIX 2N
Applicant
BAY X-RAY, INC.
1630 north main st.,
suite 101
walnut creek,  CA  94596
Applicant Contact slobodan djordjevic
Correspondent
BAY X-RAY, INC.
1630 north main st.,
suite 101
walnut creek,  CA  94596
Correspodent Contact slobodan djordjevic
Regulation Number892.1650
Classification Product Code
JAA  
Date Received07/26/1988
Decision Date 10/21/1988
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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