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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 K052057
Device Name LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR
Applicant
MEDTRONIC EMERGENCY RESPONSE SYSTEMS, INC.
11811 WILLOWS RD., N.E.
PO BOX 97006
REDMOND,  WA  98073
Applicant Contact SHERRI POCOCK
Correspondent
MEDTRONIC EMERGENCY RESPONSE SYSTEMS, INC.
11811 WILLOWS RD., N.E.
PO BOX 97006
REDMOND,  WA  98073
Correspondent Contact SHERRI POCOCK
Regulation Number870.5310
Classification Product Code
MKJ  
Date Received07/29/2005
Decision Date 02/17/2006
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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