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510(k) K990500

KENDALL ULTRAMER COUDE FOLEY CATHETER, MODEL 1416C, KENDALL CURITY COUDE FOLEY CATHETER TRAY, MODEL 6946C by The Kendal Co. — Product Code EZL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 28, 1999
Date Received
February 17, 1999
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Retention Type, Balloon
Device Class
Class II
Regulation Number
876.5130
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)
  • K892438 — KENDALL CURITY INTRAVASCULAR CUT DOWN TUBES (July 24, 1989)
  • K892440 — KENDALL CURITY EXTENSION TUBES (July 24, 1989)
  • K892436 — KENDALL CURITY IRRIGATION SYRINGE (July 14, 1989)

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