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510(k) K852831

NON-KOR ACCESS KITS by Creative Care Systems, Inc. — Product Code FMI

Clearance Details

Decision
SESD (Substantially Equivalent (with conditions))
Decision Date
September 19, 1985
Date Received
July 2, 1985
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.

  • K861406 — NON-KOR WINGED INFUSION SETS (May 6, 1986)
  • 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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