FDA 510(k) Application Details - K944952

Device Classification Name System, X-Ray, Angiographic

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510(K) Number K944952
Device Name System, X-Ray, Angiographic
Applicant ACOMA MEDICAL IMAGING, INC.
150 CHADDICK DR.
WHEELING, IL US
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Contact JAMES LAMBRECHT
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Regulation Number 892.1600

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Classification Product Code IZI
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Date Received 10/07/1994
Decision Date 02/17/1995
Decision SE - Substantially Equivalent
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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