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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, Diagnostic
510(k) Number K950037
Device Name N 800 HF
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 Number892.1700
Classification Product Code
IZO  
Date Received01/04/1995
Decision Date 02/15/1995
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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