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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, percutaneous
510(k) Number K111556
Device Name GLIDECROSS SUPPORT CATHETER
Applicant
TERUMO MEDICAL CORP.
950 Elkton Blvd.
Elkton,  MD  21921
Applicant Contact MARK UNTERREINER
Correspondent
TERUMO MEDICAL CORP.
950 Elkton Blvd.
Elkton,  MD  21921
Correspondent Contact MARK UNTERREINER
Regulation Number870.1250
Classification Product Code
DQY  
Date Received06/06/2011
Decision Date 07/29/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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