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510(k) K122544

TERUMO SURFLASH SAFETY I.V. CATHETER by Terumo Corporation — Product Code FOZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 5, 2012
Date Received
August 21, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Device Class
Class II
Regulation Number
880.5200
Review Panel
HO
Submission Type

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