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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Pacemaker, Temporary
510(k) Number K890988
Device Name MODEL 3110 HEART WIRE & 3110P PEDIATRIC HEART WIRE
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
LDF  
Date Received02/27/1989
Decision Date 08/25/1989
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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