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510(k) K771364

LUBE JEL by Travenol Laboratories, S.A. — Product Code FHX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 2, 1977
Date Received
July 25, 1977
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 Travenol Laboratories, S.A.

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  • K873894 — CONTINU-FLO SOLUTION W/CHECK VALVE 2 Y-INJECT SITE (November 5, 1987)
  • K873873 — RESUBMITTED MICRON TRANSFUSION FILTER (October 22, 1987)
  • K873984 — AUTOMATIC PERITONEAL DIALYSIS CYCLER SET (5C4437) (October 20, 1987)
  • K872364 — HEMODIALYSIS (SPS), MODEL 550, CODE 5M1309 (October 13, 1987)
  • K872652 — UPGRADED AUTO PERITONEAL DIALYSIS CYCLER SYSTEM (September 30, 1987)
  • K870801 — FLO-GARD 6200 VOLUMETRIC INFUSION/PUMPING BLOOD (September 4, 1987)
  • K871908 — IV ADMINISTRATION SET (July 27, 1987)
  • K871471 — CAPILLARY FLOW DIALYZERS MODELS ST-12 & ST-15 (June 12, 1987)
  • K865029 — CONTINU-FLO SOLUTION ADMIN. SET W/IN-LINE FILTER (April 17, 1987)

Other clearances for product code FHX

  • K081990 — LUBRICANO STERILE GEL (December 5, 2008)
  • 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)