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510(k) K852083

THE KENDALL URINARY OUTPUT MONITOR by The Kendal Co. — Product Code FFO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 20, 1985
Date Received
May 13, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Retractor, Self-Retaining
Device Class
Class I
Regulation Number
876.4730
Review Panel
GU
Submission Type

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  • 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)

Other clearances for product code FFO

  • K993544 — SPACE-OR RETRACTOR (December 22, 1999)
  • K870897 — KODNER ANAL PERIONEAL RETRACTOR (June 4, 1987)
  • K860368 — URDYN 5000 (UROFLOWMETER) (April 23, 1986)
  • K853119 — URODYN 1000 (October 4, 1985)