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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 K022732
Device Name INFANT/CHILD REDUCED ENERGY ELECTRODES
Applicant
MEDTRONIC PHYSIO-CONTROL CORP.
11811 WILLOWS RD., N.E.
REDMOND,  WA  98073
Applicant Contact SHERRI L POCOCK
Correspondent
MEDTRONIC PHYSIO-CONTROL CORP.
11811 WILLOWS RD., N.E.
REDMOND,  WA  98073
Correspondent Contact SHERRI L POCOCK
Regulation Number870.5310
Classification Product Code
MKJ  
Subsequent Product Code
MLN  
Date Received08/16/2002
Decision Date 12/13/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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