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510(k) K122834

POLYSITE IMPLANTABLE INFUSION PORTS by Perouse Medical — Product Code LJT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 11, 2013
Date Received
September 17, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Port & Catheter, Implanted, Subcutaneous, Intravascular
Device Class
Class II
Regulation Number
880.5965
Review Panel
HO
Submission Type

Other clearances by Perouse Medical

  • K123035 — SEAL ONE (November 28, 2012)
  • K120261 — PPS PI PRESSURE INJECTABLE SAFETY HUBER NEEDLE WITHOUT LATERAL INJECTION SITE, P (May 2, 2012)

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