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510(k) K897065

PORT INFUSION SET (PIS) INFUSION SET (IS) by Prn Services, Inc. — Product Code FPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 16, 1990
Date Received
December 20, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Administration, Intravascular
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type

Other clearances by Prn Services, Inc.

  • K943206 — VARIOUS TUBING (March 9, 1995)
  • K902330 — E-Z FLO + SET (September 21, 1990)
  • K882598 — 250 ML BAG W/Y INJECT. & 12 EXTENSION SET (November 1, 1988)
  • K884053 — PRN PLUS + INFUSION SET (October 31, 1988)
  • K875155 — 60 ML RESERVOIR BAG, ITEM #200 (February 16, 1988)
  • K860222 — 70 ML RESERVOIR BAG AND ADMINISTRATION SETS (June 9, 1986)

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