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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Holder, Radiographic Cassette, Wall-Mounted
510(k) Number K853756
Device Name DYNAMIC CARDIAC PHANTOM 74-347
Applicant
Victoreen, Inc.
100 Voice Rd.
Carle Place,  NY  11514
Applicant Contact GLASSER
Correspondent
Victoreen, Inc.
100 Voice Rd.
Carle Place,  NY  11514
Correspondent Contact GLASSER
Regulation Number892.1880
Classification Product Code
IXY  
Date Received09/09/1985
Decision Date 10/29/1985
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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