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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 K024247
Device Name SKINTACT ECG ELECTRODES WITH KL 02 LIQUID GEL
Applicant
LEONHARD LANG GMBH
P.O. BOX 560
STILLWATER,  MN  55082 -0560
Applicant Contact ELAINE DUNCAN
Correspondent
LEONHARD LANG GMBH
P.O. BOX 560
STILLWATER,  MN  55082 -0560
Correspondent Contact ELAINE DUNCAN
Regulation Number870.2360
Classification Product Code
DRX  
Date Received12/23/2002
Decision Date 01/16/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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