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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 K900519
Device Name CLASSIC ECG/STIMULATING NO. 1700 SERIES
Applicant
Classic Medical Products, Inc.
S82 W 19246 Apollo Dr.
Muskego,  WI  53150
Applicant Contact ROBERT A MACUR
Correspondent
Classic Medical Products, Inc.
S82 W 19246 Apollo Dr.
Muskego,  WI  53150
Correspondent Contact ROBERT A MACUR
Regulation Number870.2360
Classification Product Code
DRX  
Date Received02/02/1990
Decision Date 03/19/1990
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
Recalls CDRH Recalls
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