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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Therapeutic, X-Ray
510(k) Number K923584
Device Name THERAPAX DXT 300 SERIES 3
Applicant
Oldelft Corp. of America
2735 Dorr Ave.
Fairfax,  VA  22031
Applicant Contact CHARLES PATTIE
Correspondent
Oldelft Corp. of America
2735 Dorr Ave.
Fairfax,  VA  22031
Correspondent Contact CHARLES PATTIE
Regulation Number892.5900
Classification Product Code
JAD  
Date Received07/20/1992
Decision Date 01/15/1993
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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