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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)
510(k) Number K860283
Device Name AMI CARDIO-PAD
Applicant
Andover Medical, Inc.
23 Ballard Way
Lawrence,  MA  01843
Applicant Contact THOMAS
Correspondent
Andover Medical, Inc.
23 Ballard Way
Lawrence,  MA  01843
Correspondent Contact THOMAS
Regulation Number870.5550
Classification Product Code
DRO  
Date Received01/28/1986
Decision Date 03/31/1986
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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