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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 K882067
Device Name MARQUETTE 1200 DEFIBRILLATOR
Applicant
Marquette Electronics, Inc.
8200 W. Tower Ave.
Milwaukee,  WI  53223
Applicant Contact THOMAS MASSOPUST
Correspondent
Marquette Electronics, Inc.
8200 W. Tower Ave.
Milwaukee,  WI  53223
Correspondent Contact THOMAS MASSOPUST
Regulation Number870.5310
Classification Product Code
MKJ  
Date Received05/17/1988
Decision Date 11/17/1988
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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