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510(k) K760552

THERMOMETER STAND AND DUST COVER by Landmark Plastics — Product Code FLK

K760552 is an FDA 510(k) premarket notification submitted by Landmark Plastics for the device "THERMOMETER STAND AND DUST COVER". The FDA issued a decision of Substantially Equivalent on November 12, 1976. The device falls under product code FLK (Thermometer, Clinical Mercury), a Class II device regulated under 21 CFR 880.2920. Landmark Plastics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 12, 1976
Date Received
August 30, 1976
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 Landmark Plastics

  • K760490 — BEDPAN, GENERAL MEDICAL MEDI-PAK (November 12, 1976)
  • K760517 — CUP, DISPOSABLE MEDICINE (November 12, 1976)
  • K760493 — DISH, SOAP (November 12, 1976)
  • K760497 — TRAY, SERVICE (November 12, 1976)
  • K760495 — BASIN, RECTANGULAR WASH (November 12, 1976)
  • K760496 — CUP, DISPOSABLE SPECIMEN (November 12, 1976)
  • K760492 — BASIN, LARGE OR SMALL (November 12, 1976)
  • K760494 — BASIN, ROUND WASH (November 12, 1976)
  • K760548 — CARAFE AND LINER (November 12, 1976)
  • K760491 — TUMBLER, GENERAL MEDICAL MEDI-PAK (September 15, 1976)

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)
  • K923225 — LORREX HEALTH PRODUCTS - CLINICAL MERCURY THERMOME (June 8, 1993)
  • K913793 — SIMPEX INC. ORAL AND RECTAL THERMOMETERS (December 30, 1991)

FDA data resources