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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K904032
Device Name ELITE II ELECTROCARDIOGRAPH
Applicant
Burdick Corp.
15 Plumb St.
Miltoon,  WI  53563
Applicant Contact FRANCIS DOMINY
Correspondent
Burdick Corp.
15 Plumb St.
Miltoon,  WI  53563
Correspondent Contact FRANCIS DOMINY
Classification Product Code
LOS
Date Received08/31/1990
Decision Date 07/24/1991
Decision Substantially Equivalent (SESE)
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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