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510(k) K955535

LOUISVILLE LABS OXYGEN HEAD TENT by Louisville Laboratories, Inc. — Product Code CBF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 1, 1996
Date Received
December 5, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Chamber, Hyperbaric
Device Class
Class II
Regulation Number
868.5470
Review Panel
AN
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)
  • 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)
  • K946282 — UNIVERSAL URETHRAL CATHETER (March 31, 1995)
  • K932979 — EXTERNAL STABILITY PAD (November 2, 1993)

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