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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 K902606
Device Name RADIOPAQUE RULER
Applicant
Professional Medical Services
P.O. Box 250
700 W. 200 N.
North Salt Lake,  UT  84054
Applicant Contact JAMES E WILLIAMS
Correspondent
Professional Medical Services
P.O. Box 250
700 W. 200 N.
North Salt Lake,  UT  84054
Correspondent Contact JAMES E WILLIAMS
Regulation Number892.1680
Classification Product Code
KPR  
Date Received06/12/1990
Decision Date 09/27/1990
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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