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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Assembly, Tube Housing, X-Ray, Diagnostic
510(k) Number K923094
Device Name MOLYBDENUM
Applicant
Southeastern Medical Diagnostics, Inc.
P.O. Box 10173
Greensboro,  NC  27404
Applicant Contact PETER GRATALE
Correspondent
Southeastern Medical Diagnostics, Inc.
P.O. Box 10173
Greensboro,  NC  27404
Correspondent Contact PETER GRATALE
Regulation Number892.1760
Classification Product Code
ITY  
Date Received06/25/1992
Decision Date 03/04/1993
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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