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510(k) K890095

PVC EMPTY SOLUTION CONTAINER W/3 LEAD TRANSFER SET by Kells Medical, Inc. — Product Code KPE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 24, 1989
Date Received
January 10, 1989
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 Kells Medical, Inc.

  • K926333 — CPR PLUS (November 8, 1993)
  • K890093 — PVC EMPTY SOLUTION CONTAINER ENTERAL PUMP SET (July 24, 1989)
  • K890094 — EVA EMPTY SOLUTION CONTAINER W/3 LEAD TRANSFER SET (May 24, 1989)
  • K861972 — DERMISTRIP (June 27, 1986)
  • K844463 — DERMIDRESS (January 8, 1985)
  • K844072 — DERMIZIP SKIN CLOSURE DEVICE (November 5, 1984)
  • K832678 — PHONATORY FUNCTION ANALYZER PS-77 (March 7, 1984)
  • K832667 — LUCAE'S EAR & NASAL APPLICATORS (September 29, 1983)
  • K823118 — SAY (January 7, 1983)
  • K823227 — IMPEDANCE METER ON-1 (November 22, 1982)

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