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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 K120350
Device Name EXTENDED LIFE BATTERY
Applicant
Aed Battery Exchange, LLC
1000 Brown St.
Suite 310
Wauconda,  IL  60084
Applicant Contact KEITH HOCHHALTER
Correspondent
Aed Battery Exchange, LLC
1000 Brown St.
Suite 310
Wauconda,  IL  60084
Correspondent Contact KEITH HOCHHALTER
Regulation Number870.5310
Classification Product Code
MKJ  
Date Received02/06/2012
Decision Date 11/01/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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