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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, Tomography, Computed
510(k) Number K955583
Device Name VIFS
Applicant
Konica Medical Corp.
C/O Storch Amini & Munves, P.C
1090 Vermont Ave. NW, Suite 800
Washington,  DC  20005
Applicant Contact RUSSELL D MUNVES
Correspondent
Konica Medical Corp.
C/O Storch Amini & Munves, P.C
1090 Vermont Ave. NW, Suite 800
Washington,  DC  20005
Correspondent Contact RUSSELL D MUNVES
Regulation Number892.1750
Classification Product Code
JAK  
Date Received12/05/1995
Decision Date 05/14/1996
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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