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510(k) K832470

INFUSION PUMP by Delta Medical Industries — Product Code FRN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 28, 1984
Date Received
July 26, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Infusion
Device Class
Class II
Regulation Number
880.5725
Review Panel
HO
Submission Type

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  • K820482 — ACCU-RYNGE INSULIN PUMP #SP-250 (March 26, 1982)
  • K810068 — PEDIATRIC ARTERIAL BLOOD FILTER (January 22, 1981)
  • K802755 — ARTERIAL BLOOD FILTER BF-37 (January 7, 1981)
  • K803101 — PREBYPASS FILTER CAT.#K-5 (December 22, 1980)

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