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510(k) K181904

5 FR Dual Lumen Piper PICC by Piper Access, LLC — Product Code LJS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 25, 2018
Date Received
July 16, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Device Class
Class II
Regulation Number
880.5970
Review Panel
HO
Submission Type

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