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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Applicator, Radionuclide, Remote-Controlled
510(k) Number K001825
Device Name STANDARD IMAGING HDR 1000 PLUS ION CHAMBER; STANDARD IMAGING IVB 1000 ION CHAMBER
Applicant
Standard Imaging, Inc.
7601 Murphy Dr.
Middleton,  WI  53562 -2766
Applicant Contact RAYMOND RIDDLE
Correspondent
Standard Imaging, Inc.
7601 Murphy Dr.
Middleton,  WI  53562 -2766
Correspondent Contact RAYMOND RIDDLE
Regulation Number892.5700
Classification Product Code
JAQ  
Subsequent Product Code
IWJ  
Date Received06/16/2000
Decision Date 08/02/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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