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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name automated external defibrillators (non-wearable)
510(k) Number K072233
Device Name SKINTACT MULTIFUNCTIONAL ELECTRODES WITH DH02 GEL WITH DIFFERENT CONNECTORS COMPATIBLE WITH DIFFERENT DEFIBRILLATORS
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 Number870.5310
Classification Product Code
MKJ  
Date Received08/10/2007
Decision Date 10/05/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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