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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Generator, High Voltage, X-Ray, Therapeutic
510(k) Number K860469
Device Name 37-701-1 PATIENT DOASE MONITOR WITH DETECTORS
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 Number892.5900
Classification Product Code
KPZ  
Date Received02/06/1986
Decision Date 04/16/1986
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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