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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 K080421
Device Name HEART SYNC, MODELS C-100 AND T-100
Applicant
HEART SYNC LLC
5643 PLYMOUTH ROAD
ANN ARBOR,  MI  48105
Applicant Contact STEPHEN SHULMAN
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number870.5310
Classification Product Code
MKJ  
Subsequent Product Code
MLN  
Date Received02/15/2008
Decision Date 02/29/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Recalls CDRH Recalls
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