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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 K884494
Device Name DAIG OBTURATOR, CATHETER 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 Received10/25/1988
Decision Date 02/22/1989
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
Recalls CDRH Recalls
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