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510(k) K971801

LAPAROTOMY BLADDER NECK SUSPENSION KIT by Louisville Laboratories, Inc. — Product Code EZL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 22, 1997
Date Received
May 15, 1997
Clearance Type
Traditional
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

Other clearances by Louisville Laboratories, Inc.

  • K980123 — CARTER-THOMASON NEEDLE-POINT SUTURE PASSER INSTRUMENT SET (March 9, 1998)
  • K971796 — LAPAROTOMY BLADDER NECK SUSPENSION KIT WITH BONE ANCHORS (August 12, 1997)
  • K971791 — VAGINAL SUTURING KIT FOR LAPAROTOMY BLADDER NECK SUSPENSION (July 30, 1997)
  • K971802 — VAGINAL SUTURING KIT FOR BLADDER NECK SUSPENSION (July 30, 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)
  • K946282 — UNIVERSAL URETHRAL CATHETER (March 31, 1995)
  • K932979 — EXTERNAL STABILITY PAD (November 2, 1993)

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