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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 K791140
Device Name PREGELLED DISPOSABLE EELCTRO. SERIES 600
Applicant
Hayes Products, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Hayes Products, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number870.2360
Classification Product Code
DRX  
Date Received06/18/1979
Decision Date 07/10/1979
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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