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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, Therapeutic, Short-Term Less Than 30 Days
510(k) Number K082362
Device Name SURSHIELD SAFETY I.V. CATHETER
Applicant
Terumo Medical Corp.
950 Elkton Blvd.
Elkton,  MD  21921
Applicant Contact EILEEN DORSEY
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received08/18/2008
Decision Date 09/17/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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