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510(k) K811365

HILL TOP CHAMBER by Hill Top Research, Inc. — Product Code KXF

K811365 is an FDA 510(k) premarket notification submitted by Hill Top Research, Inc. for the device "HILL TOP CHAMBER". The FDA issued a decision of Substantially Equivalent on August 20, 1981. 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
August 20, 1981
Date Received
May 14, 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)
  • K813506 — FARRORS TMJ CASSETTE HOLDER (January 29, 1982)
  • K802580 — SUBCLAVIAN CATHETER INSERTION TRAY (November 12, 1980)

FDA data resources