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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Computer, Diagnostic, Programmable
510(k) Number K922528
Device Name CMS SYSTEM
Applicant
Micromedical Industries, Ltd.
255 Revere Dr.
Suite 101
Northbrook,  IL  60062
Applicant Contact HARRY PLATT
Correspondent
Micromedical Industries, Ltd.
255 Revere Dr.
Suite 101
Northbrook,  IL  60062
Correspondent Contact HARRY PLATT
Regulation Number870.1425
Classification Product Code
DQK  
Date Received05/28/1992
Decision Date 05/12/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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