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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pulse-Generator, Pacemaker, External
510(k) Number K871915
Device Name MINIATURE TEMP. CARDIAC PACEMAKERS EC4542 & EC4543
Applicant
Pace Medical
391 Totten Pond Rd.
Waltham,  MA  02451
Applicant Contact RALPH E HANSON
Correspondent
Pace Medical
391 Totten Pond Rd.
Waltham,  MA  02451
Correspondent Contact RALPH E HANSON
Regulation Number870.3600
Classification Product Code
DTE  
Date Received05/18/1987
Decision Date 06/10/1987
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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