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510(k) K120894

HAYMAX by Haymax Limited — Product Code NUP

K120894 is an FDA 510(k) premarket notification submitted by Haymax Limited for the device "HAYMAX". The FDA issued a decision of Substantially Equivalent on May 17, 2012. The device falls under product code NUP (Cream, Nasal, Topical, Mechanical Allergen Particle Barrier), a Class II device regulated under 21 CFR 880.5045.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 17, 2012
Date Received
March 23, 2012
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.

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  • K134003 — RHINIX NASAL FILTER (September 4, 2014)
  • K132520 — NASAL EASE ALLERGY BLOCKER (December 31, 2013)
  • K053625 — NASALGUARD (February 22, 2006)
  • K042610 — DR. THEISS ALERGOL POLLEN BLOCKER CREAM (May 16, 2005)

FDA data resources