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510(k) K955709

WINGED & SUBCUTANEOUS INFUSION SETS by Distronic Sterile Products, Inc. — Product Code FPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 21, 1996
Date Received
December 18, 1995
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 Distronic Sterile Products, Inc.

  • K955732 — VENTED SOLUTION SET (February 21, 1996)
  • K954984 — MINIBORE STOPCOCK SET (January 23, 1996)
  • K954983 — EXTENSION SET WITH CHECK VALVE (January 23, 1996)
  • K952664 — SOLUTION ADMINISTRATION SET (August 7, 1995)
  • K950597 — CORE-RESISTANT HUBER INFUSION SET WITH Y-SITE (July 26, 1995)
  • K952663 — 60 MICRO VOLUME EXTENSION SET W/.22 MICRON FILTER, 21 EXTENSION SET W/1.2 MIVTON (July 14, 1995)
  • K945184 — INTRAVASCULAR ADMINISTRATION SET (February 8, 1995)

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