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510(k) K963867

NEO-CARE CATHETERIZATION TRAY by Klein-Baker Medical, Inc. — Product Code FOZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 6, 1996
Date Received
September 26, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Device Class
Class II
Regulation Number
880.5200
Review Panel
HO
Submission Type

Other clearances by Klein-Baker Medical, Inc.

  • K972731 — NEO-CARE PERITONEAL DIALYSIS ADMINISTRATION SET (September 29, 1997)
  • K970997 — NEO-CARE LUMBER PUNCTURE KIT (May 22, 1997)
  • K970434 — NEO-PICC (April 1, 1997)
  • K963972 — NEO-CARE DUAL LUMEN UMBILICAL CATHETER (December 24, 1996)

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