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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 K864986
Device Name ETP 300 NON-INVASIVE EXTERNAL PACEMAKER
Applicant
Medac, Inc.
7451 SW Coho Ct.
Tualatin,  OR  97062
Applicant Contact ROBERT M BOONSTRA
Correspondent
Medac, Inc.
7451 SW Coho Ct.
Tualatin,  OR  97062
Correspondent Contact ROBERT M BOONSTRA
Regulation Number870.5550
Classification Product Code
DRO  
Date Received12/22/1986
Decision Date 03/03/1987
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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