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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Shield, Protective, Personnel
510(k) Number K940539
Device Name STAND IMAGING DOSE CALIBRATOR SHIELDED WORK PLATFORM
Applicant
Standard Imaging, Inc.
6213 Middleton Springs Dr.,
Suite 205, P.O. Box 352
Middleton,  WI  53562
Applicant Contact RAYMOND T RIDDLE
Correspondent
Standard Imaging, Inc.
6213 Middleton Springs Dr.,
Suite 205, P.O. Box 352
Middleton,  WI  53562
Correspondent Contact RAYMOND T RIDDLE
Regulation Number892.6500
Classification Product Code
KPY  
Date Received02/07/1994
Decision Date 03/16/1994
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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