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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
Recalls CDRH Recalls
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