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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 K091548
Device Name AMCO REPLACEMENT BATTERY FOR PHILIPS MEDICAL MODELS BT1 AND M5070A
Applicant
AMCO INTERNATIONAL MANUFACTURING & DESIGN, INC.
377 ZANE COURT
ELIZABETH,  CO  80107
Applicant Contact ALEXANDER B HENDERSON
Correspondent
AMCO INTERNATIONAL MANUFACTURING & DESIGN, INC.
377 ZANE COURT
ELIZABETH,  CO  80107
Correspondent Contact ALEXANDER B HENDERSON
Regulation Number870.5310
Classification Product Code
MKJ  
Date Received05/27/2009
Decision Date 08/07/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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