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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Permanent Pacemaker Electrode
510(k) Number K864153
Device Name PACE IMPLANT. LEAD/TINED/ATRIAL/J/MODEL 3290
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 Number870.3680
Classification Product Code
DTB  
Date Received10/23/1986
Decision Date 01/06/1987
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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