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510(k) K201734

AllerBlock Junior by Nasaleze International, Ltd. — Product Code NUP

K201734 is an FDA 510(k) premarket notification submitted by Nasaleze International, Ltd. for the device "AllerBlock Junior". The FDA issued a decision of Substantially Equivalent on March 26, 2021. The device falls under product code NUP (Cream, Nasal, Topical, Mechanical Allergen Particle Barrier), a Class II device regulated under 21 CFR 880.5045. Nasaleze International, Ltd. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 26, 2021
Date Received
June 25, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cream, Nasal, Topical, Mechanical Allergen Particle Barrier
Device Class
Class II
Regulation Number
880.5045
Review Panel
EN
Submission Type

THE DEVICE IS INTENDED TO PROMOTE ALLEVIATION OF MILD ALLERGIC SYMPTOMS TRIGGERED BY THE INHALATION OF VARIOUS ALLERGENS.

Other clearances by Nasaleze International, Ltd.

  • K170848 — Alzair Allergy Blocker (June 14, 2017)

Other clearances for product code NUP

  • K213114 — BentrioTM Allergy Blocker (June 24, 2022)
  • K170848 — Alzair Allergy Blocker (June 14, 2017)
  • K134003 — RHINIX NASAL FILTER (September 4, 2014)
  • K132520 — NASAL EASE ALLERGY BLOCKER (December 31, 2013)
  • K120894 — HAYMAX (May 17, 2012)
  • K053625 — NASALGUARD (February 22, 2006)
  • K042610 — DR. THEISS ALERGOL POLLEN BLOCKER CREAM (May 16, 2005)

FDA data resources