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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 K973486
Device Name LIFE PAK 12
Applicant
Physio-Control Corp.
11811 Willows Rd., NE
P.O. Box 97006
Redmond,  WA  98073 -9706
Applicant Contact SHERRI L POCOCK
Correspondent
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 Received09/15/1997
Decision Date 01/09/1998
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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