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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular, Diagnostic
510(k) Number K944284
Device Name CONTROL
Applicant
Daig Corp.
14901 Deveau Pl.
Minnetonka,  MN  55345
Applicant Contact JOHN J FLEISCHHACKER
Correspondent
Daig Corp.
14901 Deveau Pl.
Minnetonka,  MN  55345
Correspondent Contact JOHN J FLEISCHHACKER
Regulation Number870.1200
Classification Product Code
DQO  
Date Received09/02/1994
Decision Date 03/03/1995
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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