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510(k) K802016

EYE APPLICATORS CAT.#980-983 by Pollak (Intl.), Ltd. — Product Code KXF

K802016 is an FDA 510(k) premarket notification submitted by Pollak (Intl.), Ltd. for the device "EYE APPLICATORS CAT.#980-983". The FDA issued a decision of Substantially Equivalent on September 16, 1980. The device falls under product code KXF (Applicator, Absorbent Tipped, Non-Sterile), a Class I device regulated under 21 CFR 880.6025. Pollak (Intl.), Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 16, 1980
Date Received
August 20, 1980
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 Pollak (Intl.), Ltd.

  • K000227 — UMBICUT (April 27, 2000)
  • K810049 — PEDICAT* (April 21, 1981)
  • K810050 — VECAFIX* (March 26, 1981)
  • K802011 — INFUSSION ALARM SYSTEM I.A.S. CAT.#1118 (October 31, 1980)
  • K802009 — FLOWCLAMP CAT.#1011 & 1012 (October 31, 1980)
  • K802017 — DRESSING CHANGE SET CAT.#910-930 (October 10, 1980)
  • K802007 — PEDIWET=GUAZE IMPREGNATED WITH PETROL (September 26, 1980)
  • K801999 — GUAZE BALLS CAT.#601-720 (September 16, 1980)
  • K802001 — LAP SPONGES CAT.#801-850 (September 16, 1980)
  • K802022 — STERILE GUAZE SWABS CAT.#301-420 (September 16, 1980)

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)
  • K811365 — HILL TOP CHAMBER (August 20, 1981)

FDA data resources