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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 K920349
Device Name PCX 1050HF RADIOGRAPHIC X-RAY GENERATOR
Applicant
Control-X, Inc.
2289 Westbrooke Dr.
Columbus,  OH  43228
Applicant Contact LASZLO ADROVITZ
Correspondent
Control-X, Inc.
2289 Westbrooke Dr.
Columbus,  OH  43228
Correspondent Contact LASZLO ADROVITZ
Regulation Number892.1700
Classification Product Code
IZO  
Date Received01/24/1992
Decision Date 02/12/1993
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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