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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 K040775
Device Name LIFEPAK 12
Applicant
Medtronic Physio-Control Corp.
11811 Willows Rd., NE
P.O. Box 97006
Redmond,  WA  98073 -9706
Applicant Contact MICHELLE ACKERMANN
Correspondent
Medtronic Physio-Control Corp.
11811 Willows Rd., NE
P.O. Box 97006
Redmond,  WA  98073 -9706
Correspondent Contact MICHELLE ACKERMANN
Regulation Number870.5310
Classification Product Code
MKJ  
Date Received03/26/2004
Decision Date 04/23/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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