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510(k) K972731

NEO-CARE PERITONEAL DIALYSIS ADMINISTRATION SET by Klein-Baker Medical, Inc. — Product Code KDJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 1997
Date Received
July 22, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Administration, For Peritoneal Dialysis, Disposable
Device Class
Class II
Regulation Number
876.5630
Review Panel
GU
Submission Type

Other clearances by Klein-Baker Medical, Inc.

  • 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)
  • K963867 — NEO-CARE CATHETERIZATION TRAY (November 6, 1996)

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