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510(k) K973546

KENDALL FAST-CATH PRE LUBRICATED URETHRAL CATHETER by Kendall Healthcare Products Co. Div.Of Tyco Health — Product Code EZD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 7, 1997
Date Received
September 18, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Straight
Device Class
Class II
Regulation Number
876.5130
Review Panel
GU
Submission Type

Other clearances by Kendall Healthcare Products Co. Div.Of Tyco Health

  • K973763 — KENDALL CURITY IODOFORM PACKING STRIP (December 31, 1997)
  • K973511 — KENDALL CURITY PETROLATUM GAUZE (December 16, 1997)
  • K973507 — KENDALL XEROFORM PETROLATUM DRESSING (6311,6312,6313,6314,6315,6316,6317) (December 15, 1997)
  • K973619 — KENDALL CURITY NON-ADHERING DRESSING (December 10, 1997)
  • K973509 — KENDALL CURASORB ZN + MG ALGINATE WOUND DRESSING (December 4, 1997)
  • K970266 — KENDALL HYDROPHILIC POWDER WOUND DRESSING (April 23, 1997)
  • K963446 — KENDALL DUAL LUMEN CATHETER (March 18, 1997)
  • K964899 — KENDALL CURITY URETERAL CATHETER (February 7, 1997)
  • K964519 — CURITY THORACENTESIS TRAY (December 20, 1996)
  • K961977 — KENDALL SHER-I-BRONCH ENDOBROCHIAL TUBE (July 31, 1996)

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