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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 K002079
Device Name MULTI-FUNCTION DEFIBRILLATION ELECTRODE
Applicant
Medicotest A/S
1900 K St. NW
Washington,  DC  20006 -1108
Applicant Contact EMALEE G MURPHY
Correspondent
Medicotest A/S
1900 K St. NW
Washington,  DC  20006 -1108
Correspondent Contact EMALEE G MURPHY
Regulation Number870.5310
Classification Product Code
MKJ  
Date Received07/10/2000
Decision Date 02/22/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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