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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K974352
Device Name CARDIOVIEW 3000 SOFTWARE
Applicant
Micromedical, Inc.
255 Revere Dr., Suite 111
Northbrook,  IL  60062
Applicant Contact MALCOM CASTLE
Correspondent
Micromedical, Inc.
255 Revere Dr., Suite 111
Northbrook,  IL  60062
Correspondent Contact MALCOM CASTLE
Classification Product Code
LOS
Date Received11/19/1997
Decision Date 09/08/1998
Decision Substantially Equivalent (SESE)
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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