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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instruments, Surgical, Cardiovascular
510(k) Number K934727
Device Name REPLACEMENT PARTS FOR CPI 6888 LEAD TUNNELER
Applicant
Cardiac Pacemakers, Inc.
4100 Hamline Ave., N.
P.O. Box 64079
St. Paul,  MN  55112
Applicant Contact MICHELE C PURCELL
Correspondent
Cardiac Pacemakers, Inc.
4100 Hamline Ave., N.
P.O. Box 64079
St. Paul,  MN  55112
Correspondent Contact MICHELE C PURCELL
Regulation Number870.4500
Classification Product Code
DWS  
Date Received10/01/1993
Decision Date 01/10/1994
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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