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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 K812878
Device Name THE NEW 1600 ELECTRODE
Applicant
Andover Medical, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Andover Medical, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number870.2360
Classification Product Code
DRX  
Date Received10/14/1981
Decision Date 11/02/1981
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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