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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 K910139
Device Name VER-MED A10014 RESTING EKG ELECTRODE & A10021
Applicant
Vermont Medical, Inc.
Industrial Park
Bellows Falls,  VT  05101
Applicant Contact DAVID LOVELL
Correspondent
Vermont Medical, Inc.
Industrial Park
Bellows Falls,  VT  05101
Correspondent Contact DAVID LOVELL
Regulation Number870.2360
Classification Product Code
DRX  
Date Received01/14/1991
Decision Date 08/15/1991
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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