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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 K170848
Device Name Alzair Allergy Blocker
Applicant
Nasaleze International, Ltd.
Old Castletown Rd.
Douglas,  IM Im2 1qa
Applicant Contact Matt Duxbury
Correspondent
Nasaleze International, Ltd.
Old Castletown Rd.
Douglas,  IM Im2 1qa
Correspondent Contact Matt Duxbury
Regulation Number880.5045
Classification Product Code
NUP  
Date Received03/21/2017
Decision Date 06/14/2017
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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