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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)
510(k) Number K912599
Device Name QUIK-PACE(R) OR EX-PACE(TM) PEDIATRIC PACING ELEC
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 Number870.5550
Classification Product Code
DRO  
Date Received06/10/1991
Decision Date 09/11/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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