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510(k) K923225

LORREX HEALTH PRODUCTS - CLINICAL MERCURY THERMOME by Lorrex Health Products — Product Code FLK

K923225 is an FDA 510(k) premarket notification submitted by Lorrex Health Products for the device "LORREX HEALTH PRODUCTS - CLINICAL MERCURY THERMOME". The FDA issued a decision of Substantially Equivalent on June 8, 1993. The device falls under product code FLK (Thermometer, Clinical Mercury), a Class II device regulated under 21 CFR 880.2920. Lorrex Health Products has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 8, 1993
Date Received
July 1, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Thermometer, Clinical Mercury
Device Class
Class II
Regulation Number
880.2920
Review Panel
HO
Submission Type

Other clearances by Lorrex Health Products

  • K945553 — ROUND STICK SPONGES, FLAT STICK SPONGES (December 28, 1994)
  • K945606 — TRIANGULAR SPONGES (December 28, 1994)
  • K945866 — CYLINDRICAL SPONGE (December 28, 1994)
  • K945335 — CHERRY DISSECTOR (December 28, 1994)
  • K945333 — KITTNER DISSECTOR (December 28, 1994)
  • K945334 — CHERRY PIT DISSECTOR (December 5, 1994)
  • K945332 — ROSEBUD DISSECTOR (December 5, 1994)
  • K945336 — PEANUT DISSECTOR (December 5, 1994)
  • K942824 — LORREX IV SPONGES, STERILE 2'S; LORREX DRAIN SPONGES, STERILE 2'S (August 3, 1994)
  • K942314 — LORREX GAUZE SPONGES SPECIALTY (June 2, 1994)

Other clearances for product code FLK

  • K960185 — AMSINO CLINICAL THERMOMETER (March 28, 1996)
  • K960224 — GERATHERM MERCUIRY FREE CLINICAL THERMOMETER (March 25, 1996)
  • K953465 — KENTEMP (December 15, 1995)
  • K942483 — CLINICAL GLASS THERMOMETER (March 28, 1995)
  • K941673 — MEDIAID UNIVERSAL THERMOMETER (August 25, 1994)
  • K940380 — AMG MED BRAND CLINICAL GLASS THERMOMETER (May 4, 1994)
  • K940394 — AMG MED BRAND CLINICAL GLASS THERMOMETER (May 4, 1994)
  • K932991 — GUARDIAN AND ANDINO MODELS (January 28, 1994)
  • K913793 — SIMPEX INC. ORAL AND RECTAL THERMOMETERS (December 30, 1991)
  • K911269 — MERCURY AND GLASS FEVER THERMOMETER (May 15, 1991)

FDA data resources