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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Electrocardiograph
510(k) Number K902176
Device Name SILVER MACTRODE
Applicant
Marquette Electronics, Inc.
P.O. Box 9100
100 Marquette Dr.
Jupiter,  FL  33468
Applicant Contact MICHAEL T LAUGHRAN
Correspondent
Marquette Electronics, Inc.
P.O. Box 9100
100 Marquette Dr.
Jupiter,  FL  33468
Correspondent Contact MICHAEL T LAUGHRAN
Regulation Number870.2360
Classification Product Code
DRX  
Date Received05/15/1990
Decision Date 09/04/1990
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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