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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 K914090
Device Name DAIG FAST CATH(TM) INTRODUCER, MODIFICATION
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 Received09/11/1991
Decision Date 10/28/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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