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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 K991910
Device Name LIFEPAK 12 BIPHASIC
Applicant
PHYSIO-CONTROL CORP.
11811 WILLOWS RD. N.E.
P.O. BOX 97006
REDMOND,  WA  98073 -9706
Applicant Contact MICHAEL D WILLINGHAM
Correspondent
PHYSIO-CONTROL CORP.
11811 WILLOWS RD. N.E.
P.O. BOX 97006
REDMOND,  WA  98073 -9706
Correspondent Contact MICHAEL D WILLINGHAM
Regulation Number870.5310
Classification Product Code
MKJ  
Subsequent Product Codes
DQA   DRO   LDD  
Date Received06/07/1999
Decision Date 09/03/1999
Decision SE SUBJECT TO TRACKING REG (ST)
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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