Home / 510(k) Clearances / K813506

510(k) K813506

FARRORS TMJ CASSETTE HOLDER by Brell Mar Products, Inc. — Product Code KXF

K813506 is an FDA 510(k) premarket notification submitted by Brell Mar Products, Inc. for the device "FARRORS TMJ CASSETTE HOLDER". The FDA issued a decision of Substantially Equivalent on January 29, 1982. The device falls under product code KXF (Applicator, Absorbent Tipped, Non-Sterile), a Class I device regulated under 21 CFR 880.6025.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 29, 1982
Date Received
December 15, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Applicator, Absorbent Tipped, Non-Sterile
Device Class
Class I
Regulation Number
880.6025
Review Panel
HO
Submission Type

Other clearances for product code KXF

  • K123184 — FINN CHAMBERS AQUA (December 19, 2012)
  • K103409 — ALLERGEAZE R CLEAR (March 15, 2011)
  • K063160 — ALLERGEAZE PATCH TEST CHAMBERS (December 22, 2006)
  • K013820 — FINN CHAMBER (R) (January 30, 2002)
  • K992553 — IQ CHAMBERS (April 12, 2000)
  • K870762 — EAR APPLICATOR, CATALOG NO. 2229 (March 6, 1987)
  • K843720 — COTTON TIPPED APPLICATORS, SINGLE (October 4, 1984)
  • K820962 — COTTON SWABS (April 20, 1982)
  • K811365 — HILL TOP CHAMBER (August 20, 1981)
  • K802580 — SUBCLAVIAN CATHETER INSERTION TRAY (November 12, 1980)

FDA data resources