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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name introducer, catheter
510(k) Number K894431
Device Name MODIFIED LABELING TO PERMANENT LEAD INTRODUCER
Applicant
DAIG CORP.
14901 DEVEAU PLACE
MINNETONKA,  MN  55345 -2126
Applicant Contact J FLEISCHHACKER
Correspondent
DAIG CORP.
14901 DEVEAU PLACE
MINNETONKA,  MN  55345 -2126
Correspondent Contact J FLEISCHHACKER
Regulation Number870.1340
Classification Product Code
DYB  
Date Received07/17/1989
Decision Date 09/06/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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