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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 K914185
Device Name PACEL(TM) FLOW DIRECTED PACING CATHETER
Applicant
Daig Corp.
14901 Deveau Pl.
Minnetonka,  MN  55345
Applicant Contact J FLEISCHHACKER
Correspondent
Daig Corp.
14901 Deveau Pl.
Minnetonka,  MN  55345
Correspondent Contact J FLEISCHHACKER
Regulation Number870.3680
Classification Product Code
LDF  
Date Received09/18/1991
Decision Date 01/27/1992
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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