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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Electrocardiograph
510(k) Number K982521
Device Name SKINTACT ECG ELECTRODES, S&W ECG ELECTRODES
Applicant
Leonhard Lang Co.
Archenweg 56
Innsbruck,  AT A-6010
Applicant Contact BURRHUS LANG
Correspondent
Tuv Product Service, Inc.
1775 Old Highway 8
New Brighton,  MN  55112 -1891
Regulation Number870.2360
Classification Product Code
DRX  
Date Received07/20/1998
Decision Date 10/26/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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