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510(k) K875155

60 ML RESERVOIR BAG, ITEM #200 by Prn Services, Inc. — Product Code KPE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 16, 1988
Date Received
December 15, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Container, I.V.
Device Class
Class II
Regulation Number
880.5025
Review Panel
HO
Submission Type

Other clearances by Prn Services, Inc.

  • K943206 — VARIOUS TUBING (March 9, 1995)
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  • K897065 — PORT INFUSION SET (PIS) INFUSION SET (IS) (February 16, 1990)
  • K882598 — 250 ML BAG W/Y INJECT. & 12 EXTENSION SET (November 1, 1988)
  • K884053 — PRN PLUS + INFUSION SET (October 31, 1988)
  • K860222 — 70 ML RESERVOIR BAG AND ADMINISTRATION SETS (June 9, 1986)

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