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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tools, Pacemaker Service
510(k) Number K875147
Device Name TORQUE HEX WRENCH
Applicant
Cardiac Pacemakers, Inc.
4100 Hamline Ave., N.
P.O. Box 64079
St. Paul,  MN  55112 -5798
Applicant Contact GREG MATHISON
Correspondent
Cardiac Pacemakers, Inc.
4100 Hamline Ave., N.
P.O. Box 64079
St. Paul,  MN  55112 -5798
Correspondent Contact GREG MATHISON
Regulation Number870.3730
Classification Product Code
DTF  
Date Received12/15/1987
Decision Date 01/27/1988
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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