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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Generator, High Voltage, X-Ray, Therapeutic
510(k) Number K854410
Device Name VERIFLEX
Applicant
Old Delft Corp. of America
2735 Dorr Ave.
Fairfax,  VA  22031
Applicant Contact CHARLES PATTIE
Correspondent
Old Delft Corp. of America
2735 Dorr Ave.
Fairfax,  VA  22031
Correspondent Contact CHARLES PATTIE
Regulation Number892.5900
Classification Product Code
KPZ  
Date Received11/01/1985
Decision Date 02/12/1986
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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