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510(k) K946282

UNIVERSAL URETHRAL CATHETER by Louisville Laboratories, Inc. — Product Code EZC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 31, 1995
Date Received
December 27, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Louisville Laboratories, Inc.

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  • K971791 — VAGINAL SUTURING KIT FOR LAPAROTOMY BLADDER NECK SUSPENSION (July 30, 1997)
  • K971802 — VAGINAL SUTURING KIT FOR BLADDER NECK SUSPENSION (July 30, 1997)
  • K971801 — LAPAROTOMY BLADDER NECK SUSPENSION KIT (July 22, 1997)
  • K971797 — LAPAROSCOPIC BLADDER NECK SUSPENSION KIT (July 22, 1997)
  • K963076 — LAPAROSCOPIC BONE ANCHORED URETHROPEXY INSTRUMENT TRAY (April 4, 1997)
  • K960882 — CONTROL SYRINGE (July 8, 1996)
  • K955535 — LOUISVILLE LABS OXYGEN HEAD TENT (July 1, 1996)
  • K932979 — EXTERNAL STABILITY PAD (November 2, 1993)

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