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510(k) K884053

PRN PLUS + INFUSION SET by Prn Services, Inc. — Product Code FPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 1988
Date Received
September 26, 1988
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)
  • K897065 — PORT INFUSION SET (PIS) INFUSION SET (IS) (February 16, 1990)
  • K882598 — 250 ML BAG W/Y INJECT. & 12 EXTENSION SET (November 1, 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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