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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Digital Image Communications, Radiological
510(k) Number K954567
Device Name RTI MEDICAL
Applicant
Radiology Telenetwork Intl.
2600 Virginia Ave., NW
Suite 1000
Washington,  DC  20037 -1905
Applicant Contact MARTIN J GAYNES
Correspondent
Radiology Telenetwork Intl.
2600 Virginia Ave., NW
Suite 1000
Washington,  DC  20037 -1905
Correspondent Contact MARTIN J GAYNES
Regulation Number892.2020
Classification Product Code
LMD  
Date Received09/29/1995
Decision Date 04/12/1996
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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