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510(k) K103409

ALLERGEAZE R CLEAR by Smartpractice — Product Code KXF

K103409 is an FDA 510(k) premarket notification submitted by Smartpractice for the device "ALLERGEAZE R CLEAR". The FDA issued a decision of Substantially Equivalent on March 15, 2011. The device falls under product code KXF (Applicator, Absorbent Tipped, Non-Sterile), a Class I device regulated under 21 CFR 880.6025. Smartpractice has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 15, 2011
Date Received
November 22, 2010
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 by Smartpractice

  • K123184 — FINN CHAMBERS AQUA (December 19, 2012)
  • K063160 — ALLERGEAZE PATCH TEST CHAMBERS (December 22, 2006)
  • K023232 — SPLATRFREE SWANGLE 360 DISPOSABLE PROPHYLAXIS ANGLE (December 11, 2002)

Other clearances for product code KXF

  • K123184 — FINN CHAMBERS AQUA (December 19, 2012)
  • 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)
  • K811365 — HILL TOP CHAMBER (August 20, 1981)
  • K802580 — SUBCLAVIAN CATHETER INSERTION TRAY (November 12, 1980)

FDA data resources