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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 K911883
Device Name DAIG FAST CATH(TM) TRANSSEPTAL SHEATH INTRODUCER
Applicant
DIAG CORP.
14901 DEVEAU PLACE
MINNETONKA,  MN  55345 -2126
Applicant Contact J FLEISCHHACKER
Correspondent
DIAG CORP.
14901 DEVEAU PLACE
MINNETONKA,  MN  55345 -2126
Correspondent Contact J FLEISCHHACKER
Regulation Number870.1340
Classification Product Code
DYB  
Date Received04/29/1991
Decision Date 11/29/1991
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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