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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 K953831
Device Name N 800 HF
Applicant
Nucletron-Oldelft Corp.
7080 Columbia Gateway Dr.
Columbia,  MD  21046
Applicant Contact STEPHEN P TEAGUE
Correspondent
Nucletron-Oldelft Corp.
7080 Columbia Gateway Dr.
Columbia,  MD  21046
Correspondent Contact STEPHEN P TEAGUE
Regulation Number892.1700
Classification Product Code
IZO  
Date Received08/15/1995
Decision Date 09/08/1995
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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