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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, Fluoroscopic, Image-Intensified
510(k) Number K843972
Device Name ANGIOPLUS-S
Applicant
Oec-Diasonics, Inc.
2341 S. 2300 W.
P.O. Box 25296
Salt Lake City,  UT  84119
Applicant Contact JOHN W TOLHURST
Correspondent
Oec-Diasonics, Inc.
2341 S. 2300 W.
P.O. Box 25296
Salt Lake City,  UT  84119
Correspondent Contact JOHN W TOLHURST
Regulation Number892.1650
Classification Product Code
JAA  
Date Received10/11/1984
Decision Date 01/03/1985
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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