Home / 510(k) Clearances / K854168

510(k) K854168

TRAVENOL DISPOSABLE DENTAL SCALERS/CURETTES by Travenol Laboratories, S.A. — Product Code ELA

K854168 is an FDA 510(k) premarket notification submitted by Travenol Laboratories, S.A. for the device "TRAVENOL DISPOSABLE DENTAL SCALERS/CURETTES". The FDA issued a decision of Substantially Equivalent on March 13, 1986. The device falls under product code ELA (Instrument, Hand, Calculus Removal), a Class I device regulated under 21 CFR 872.4565. Travenol Laboratories, S.A. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 13, 1986
Date Received
October 15, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Hand, Calculus Removal
Device Class
Class I
Regulation Number
872.4565
Review Panel
DE
Submission Type

Other clearances by Travenol Laboratories, S.A.

  • K874181 — BAXTER BEDSIDE SYSTEM (February 22, 1988)
  • 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 ELA

  • K952363 — OPUS PACEMAKERS (MODELS 4021, 4033, AND 4034) (August 15, 1995)
  • K823326 — DENTAL INSTRUMENTS - CUTTING INSTRUMENT (November 24, 1982)
  • K801974 — ANALYTIC TECH. METAL POINT HEATER #3001 (November 12, 1980)

FDA data resources