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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K870920
Device Name ELITE ELECTROCARDIOGRAPH
Applicant
Burdick Corp.
15 Plumb St.
Miltoon,  WI  53563
Applicant Contact FRANCIS I DOMINY
Correspondent
Burdick Corp.
15 Plumb St.
Miltoon,  WI  53563
Correspondent Contact FRANCIS I DOMINY
Classification Product Code
LOS
Date Received03/06/1987
Decision Date 04/13/1987
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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