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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name System, X-Ray, Stationary
510(k) Number K760205
Device Name RADIOGRAPHIC UNIT, XRC-1
Applicant
Xrc, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Xrc, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number892.1680
Classification Product Code
KPR  
Date Received07/09/1976
Decision Date 07/26/1976
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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