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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K923913
Device Name NOISE REDUCTION UNIT W/ LAST IMAGE HOLD
Applicant
Jms Imaging Products, Inc.
739 Fullerton Ave.
Addison,  IL  60101
Applicant Contact EDWARD G DETWILER
Correspondent
Jms Imaging Products, Inc.
739 Fullerton Ave.
Addison,  IL  60101
Correspondent Contact EDWARD G DETWILER
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received08/04/1992
Decision Date 10/22/1992
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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