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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Continuous Flush
510(k) Number K033913
Device Name PROGREAT
Applicant
Terumo Medical Corp.
125 Blue Ball Rd.
Elkton,  MD  21921
Applicant Contact MARK UNTERREINER
Correspondent
Terumo Medical Corp.
125 Blue Ball Rd.
Elkton,  MD  21921
Correspondent Contact MARK UNTERREINER
Regulation Number870.1210
Classification Product Code
KRA  
Date Received12/17/2003
Decision Date 03/11/2004
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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