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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 K090040
Device Name RADIFOCUS GLIDECATH (OR RADIFOCUS GLIDECATH XP)
Applicant
Terumo Medical Corp.
950 Elkton Blvd.
Elkton,  MD  21921
Applicant Contact MARK UNTERREINER
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number870.1200
Classification Product Code
DQO  
Date Received01/06/2009
Decision Date 02/06/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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