FDA 510(k) Application Details - K962140

Device Classification Name System, X-Ray, Fluoroscopic, Image-Intensified

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510(K) Number K962140
Device Name System, X-Ray, Fluoroscopic, Image-Intensified
Applicant CONTINENTAL X-RAY CORP.
2000 SOUTH 25TH AVE.
BROADVIEW, IL 60153 US
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Contact OSCAR KHUTORYANSKY
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Regulation Number 892.1650

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Classification Product Code JAA
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Date Received 06/03/1996
Decision Date 07/25/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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