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510(k) K840681

DAYPAK SYSTEM III CATHETER CARE KIT by Creative Care Systems, Inc. — Product Code LJS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 16, 1984
Date Received
February 15, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Device Class
Class II
Regulation Number
880.5970
Review Panel
HO
Submission Type

Other clearances by Creative Care Systems, Inc.

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

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