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510(k) K970969

KENDALL CURITY SUPRAPUBIC CATHETER TRAY, KIT, & REPLACEMENT SET by The Kendal Co. — Product Code KOB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 23, 1997
Date Received
March 17, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Suprapubic (And Accessories)
Device Class
Class II
Regulation Number
876.5090
Review Panel
GU
Submission Type

Other clearances by The Kendal Co.

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  • K991758 — MONOJECT INSULIN SYRINGE (June 14, 1999)
  • K951488 — KENDALL CURITY CATHETER PLUG WITH PROTECTIVE CAP (April 25, 1995)
  • K942664 — KENDALL MODEL 6325 SCD SEQUEL COMPRESSION SYSTEM (January 17, 1995)
  • K942774 — POLYSKIN(R) M.R. MOIST RESPONSIVE TRANSPARENT DRESSING (July 20, 1994)
  • K892434 — KENDALL CURITY OXYGEN MASK (August 15, 1989)
  • K892440 — KENDALL CURITY EXTENSION TUBES (July 24, 1989)
  • K892438 — KENDALL CURITY INTRAVASCULAR CUT DOWN TUBES (July 24, 1989)
  • K892436 — KENDALL CURITY IRRIGATION SYRINGE (July 14, 1989)

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  • K182066 — O'Brien Suprapubic Introducer Set, Cook SP Tube Introducer Set (October 30, 2018)
  • K132890 — SUPRAPUBIC CATHETER AND INTRODUCER SET (January 17, 2014)
  • K120127 — SWAN VALLEY MEDICAL TRANURETHRAL SUPRAPUBIC ENDO-CYSTOSTOMY (T-SPEC) SURGICAL SY (October 26, 2012)
  • K014002 — ALL SILICONE SUPRA-PUBIA CATHETER, MODELS 4880/4890 (March 4, 2002)
  • K012153 — LOWSLEY SUPRAPUBIC TRACTOR (September 19, 2001)
  • K970021 — RUSCH SUPRAPUBIC TRAY (February 7, 1997)
  • K945480 — MOSS(R) STEEL BREAKAWAY(R) INTRODUCER (August 28, 1995)