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510(k) K951713

BUTTON LUBRICATOR by Fibertech Instruments, Inc. — Product Code FHX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 25, 1995
Date Received
April 14, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Jelly, Lubricating, For Transurethral Surgical Instrument
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

Other clearances by Fibertech Instruments, Inc.

  • K940780 — SCOPEJOCKEY (May 10, 1994)

Other clearances for product code FHX

  • K081990 — LUBRICANO STERILE GEL (December 5, 2008)
  • K935548 — CATHEJELL S STERILE LUBRICATING JELLY (March 30, 1994)
  • K912132 — OPERAND LUBRICATING JELLY (August 7, 1991)
  • K780386 — K-Y LUBRICATING JELLY (April 13, 1978)
  • K771364 — LUBE JEL (August 2, 1977)