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510(k) K861406

NON-KOR WINGED INFUSION SETS by Creative Care Systems, Inc. — Product Code FMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 6, 1986
Date Received
April 15, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Hypodermic, Single Lumen
Device Class
Class II
Regulation Number
880.5570
Review Panel
HO
Submission Type

Other clearances by Creative Care Systems, Inc.

  • K852831 — NON-KOR ACCESS KITS (September 19, 1985)
  • K850888 — PERCUTANEOUS CV CATHETER INSERTION KIT W OR W/O CV (May 7, 1985)
  • K850887 — DRESSING CHANGE KIT (May 1, 1985)
  • K841742 — NON-CORING NEEDLE (July 6, 1984)
  • K840919 — DAYPAK SYS VII CATHETER CARE KIT (April 17, 1984)
  • K840681 — DAYPAK SYSTEM III CATHETER CARE KIT (April 16, 1984)

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