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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 K073104
Device Name SKINTACT AND VARIOUS OTHER TRADENAMES
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 Received11/02/2007
Decision Date 11/16/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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