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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 K902848
Device Name FASTRECON 88 PERIFERAL
Applicant
Scientific Technology , Ltd.
Consulting And Design
2121 Richwood Dr.
Garland,  TX  75044
Applicant Contact JAMES R HERRINGTON
Correspondent
Scientific Technology , Ltd.
Consulting And Design
2121 Richwood Dr.
Garland,  TX  75044
Correspondent Contact JAMES R HERRINGTON
Regulation Number892.1750
Classification Product Code
JAK  
Date Received06/28/1990
Decision Date 08/01/1990
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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