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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Transmitters And Receivers, Physiological Signal, Radiofrequency
510(k) Number K891104
Device Name CD TELEMETRY SYSTEMS
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 Number870.2910
Classification Product Code
DRG  
Date Received03/02/1989
Decision Date 04/19/1989
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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