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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, Mammographic
510(k) Number K871592
Device Name RF-1 CIRCUIT
Applicant
Diagnostic Imaging Specialists Corp.
163 St. Malo St.
St. Malo, Manitoba,  CA R0A1T0
Applicant Contact GELSKEY, PHD
Correspondent
Diagnostic Imaging Specialists Corp.
163 St. Malo St.
St. Malo, Manitoba,  CA R0A1T0
Correspondent Contact GELSKEY, PHD
Regulation Number892.1710
Classification Product Code
IZH  
Date Received04/24/1987
Decision Date 05/22/1987
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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