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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, Angiographic
510(k) Number K924137
Device Name CSP-A (CEILING SUSPENDED POSITIONER-ANGIO)
Applicant
Fischer Imaging Corp.
12300 N. Grant St.
Denver,  CO  80241
Applicant Contact JAMES W MORGAN
Correspondent
Fischer Imaging Corp.
12300 N. Grant St.
Denver,  CO  80241
Correspondent Contact JAMES W MORGAN
Regulation Number892.1600
Classification Product Code
IZI  
Date Received08/18/1992
Decision Date 12/28/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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