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510(k) K081990

LUBRICANO STERILE GEL by Farco Pharma GmbH — Product Code FHX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 5, 2008
Date Received
July 14, 2008
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 Farco Pharma GmbH

  • K083358 — LUBRICANO-ULTRASOUND (January 9, 2009)

Other clearances for product code FHX

  • K951713 — BUTTON LUBRICATOR (April 25, 1995)
  • 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)