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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tester, Electrode, Surface, Electrocardiographic
510(k) Number K771014
Device Name TS-100 TEST SYSTEM
Applicant
DELTA MEDICAL INDUSTRIES
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
DELTA MEDICAL INDUSTRIES
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number870.2370
Classification Product Code
KRC  
Date Received06/06/1977
Decision Date 06/14/1977
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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