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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 K073716
Device Name LIFE+CEL OR LIFECEL BATTERY
Applicant
Amco International Manufacturing & Design, Inc.
377 Zane Court
Hillside Village
Elizabeth,  CO  80107
Applicant Contact ALEX HENDERSON
Correspondent
Amco International Manufacturing & Design, Inc.
377 Zane Court
Hillside Village
Elizabeth,  CO  80107
Correspondent Contact ALEX HENDERSON
Regulation Number870.5310
Classification Product Code
MKJ  
Date Received12/31/2007
Decision Date 04/11/2008
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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