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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 K062858
Device Name MODIFICATION TO GLIDESHEATH
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 Number870.1340
Classification Product Code
DYB  
Date Received09/25/2006
Decision Date 10/20/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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