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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dc-Defibrillator, Low-Energy, (Including Paddles)
510(k) Number K012274
Device Name MEDTRONIC PHYSIO-CONTROL LIFEPAK 20 DEFIBRILLATOR/MONITOR/PACEMAKER
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 Number870.5300
Classification Product Code
LDD  
Date Received07/19/2001
Decision Date 02/05/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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