FDA 510(k) K213114, BentrioTM Allergy Blocker, by Altamira Therapeutics, Inc.

FDA 510(k) K213114, BentrioTM Allergy Blocker, by Altamira Therapeutics, Inc.

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Device Classification Name: Cream, Nasal, Topical, Mechanical Allergen Particle Barrier
510(k) Number: K213114
Device Name: BentrioTM Allergy Blocker
Applicant: Altamira Therapeutics, Inc.
Regulation Number: 880.5045
Classification Product Code: NUP
Date Received: 09/27/2021
Decision Date: 06/24/2022
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General Hospital
510k Review Panel: Ear Nose & Throat

Total number of pages: 2,954
Fully redacted pages: 2,436
Content pages: 518

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