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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 K012428
Device Name MODIFICATION TO: LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR
Applicant
MEDTRONIC PHYSIO-CONTROL CORP.
11811 WILLOWS RD NE
P.O. BOX 97006
REDMOND,  WA  98073 -9706
Applicant Contact SHERRI L POCOCK
Correspondent
MEDTRONIC PHYSIO-CONTROL CORP.
11811 WILLOWS RD NE
P.O. BOX 97006
REDMOND,  WA  98073 -9706
Correspondent Contact SHERRI L POCOCK
Regulation Number870.5310
Classification Product Code
MKJ  
Date Received07/31/2001
Decision Date 09/28/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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