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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Quality-Assurance, Radiologic
510(k) Number K860100
Device Name MRI SLICE THICKNESS & CONTIGUITY PHANTOM #76-902
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 Number892.1940
Classification Product Code
LHO  
Date Received01/10/1986
Decision Date 04/22/1986
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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