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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Implantable Pacemaker Pulse-Generator
510(k) Number K913134
Device Name MODEL 4220
Applicant
Pace Medical
391 Totten Pond Rd.
Waltham,  MA  02451
Applicant Contact ROBERT C.MACE
Correspondent
Pace Medical
391 Totten Pond Rd.
Waltham,  MA  02451
Correspondent Contact ROBERT C.MACE
Regulation Number870.3610
Classification Product Code
DXY  
Date Received07/16/1991
Decision Date 08/22/1991
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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