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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Digital Image Communications, Radiological
510(k) Number K931795
Device Name TELERAD STAT
Applicant
Magnetic Research, Inc.
42 N. University Ave.
Suite 204
Provo,  UT  84601
Applicant Contact WENDELL GIBBY
Correspondent
Magnetic Research, Inc.
42 N. University Ave.
Suite 204
Provo,  UT  84601
Correspondent Contact WENDELL GIBBY
Regulation Number892.2020
Classification Product Code
LMD  
Date Received04/12/1993
Decision Date 11/19/1993
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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