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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pulse-Generator, Pacemaker, External
510(k) Number K970347
Device Name MPC (MODEL 7000) EXTERNAL TEMPORARY PACEMAKER SYSTEM
Applicant
Paladin Medical, Inc.
P.O. Box 560
Stillwater,  MN  55082 -0560
Applicant Contact ELAINE DUNCAN
Correspondent
Paladin Medical, Inc.
P.O. Box 560
Stillwater,  MN  55082 -0560
Correspondent Contact ELAINE DUNCAN
Regulation Number870.3600
Classification Product Code
DTE  
Date Received01/27/1997
Decision Date 08/29/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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