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510(k) K935548

CATHEJELL S STERILE LUBRICATING JELLY by Pharmazeutische Fabrik Montavit GmbH — Product Code FHX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 30, 1994
Date Received
November 17, 1993
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 for product code FHX

  • K081990 — LUBRICANO STERILE GEL (December 5, 2008)
  • K951713 — BUTTON LUBRICATOR (April 25, 1995)
  • K912132 — OPERAND LUBRICATING JELLY (August 7, 1991)
  • K780386 — K-Y LUBRICATING JELLY (April 13, 1978)
  • K771364 — LUBE JEL (August 2, 1977)