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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 K142803
Device Name Skintact, various other tradenames
Applicant
Leonhard Lang GmbH
Archenweg 56
Innsbruck,  AT 6020
Applicant Contact Burrhus Lang
Correspondent
Paladin Medical, Inc.
P.O. Box 560
Stillwater,  MN  55082
Correspondent Contact Elaine Duncan
Regulation Number870.5310
Classification Product Code
MKJ  
Date Received09/29/2014
Decision Date 12/02/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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