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510(k) K971802

VAGINAL SUTURING KIT FOR BLADDER NECK SUSPENSION by Louisville Laboratories, Inc. — Product Code MBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 30, 1997
Date Received
May 15, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fastener, Fixation, Nondegradable, Soft Tissue
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
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)
  • 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)
  • K946282 — UNIVERSAL URETHRAL CATHETER (March 31, 1995)
  • K932979 — EXTERNAL STABILITY PAD (November 2, 1993)

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