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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 K902643
Device Name FALCON DISK DRIVE SUBSYSTEM
Applicant
Sokar, Inc.
431 W. Lambert Rd.
Suite 307
Brea,  CA  92621
Applicant Contact FRANK JR.
Correspondent
Sokar, Inc.
431 W. Lambert Rd.
Suite 307
Brea,  CA  92621
Correspondent Contact FRANK JR.
Regulation Number892.1750
Classification Product Code
JAK  
Date Received06/15/1990
Decision Date 07/09/1990
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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