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U.S. Department of Health and Human Services

510(k) Premarket Notification
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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.
8 The Green
Suite B
Dover,  DE  19901
Applicant Contact Elena Cavallini
Correspondent
DuVal & Associates, P.A.
825 Nicollet Mall, Suite 1820
Medical Arts Bldg.
Minneapolis,  MN  55402
Correspondent Contact Patrick Johnson
Regulation Number880.5045
Classification Product Code
NUP  
Date Received09/27/2021
Decision Date 06/24/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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