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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 Occluding, Temporary
510(k) Number K090970
Device Name FLOCONTROL , MODEL 1028
Applicant
Coaxia, Inc.
10900 73rd Ave. N.
Maple Grove,  MN  55369
Applicant Contact SHARON D KVISTAD
Correspondent
Coaxia, Inc.
10900 73rd Ave. N.
Maple Grove,  MN  55369
Correspondent Contact SHARON D KVISTAD
Regulation Number870.4450
Classification Product Code
MJN  
Date Received04/06/2009
Decision Date 06/12/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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