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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 K201734
Device Name AllerBlock Junior
Applicant
Nasaleze International Ltd
Old Castletown Road
Douglas,  IM Im2 1qa
Applicant Contact Matt Duxbury
Correspondent
Nasaleze International Ltd
Old Castletown Road
Douglas,  IM Im2 1qa
Correspondent Contact Matt Duxbury
Regulation Number880.5045
Classification Product Code
NUP  
Date Received06/25/2020
Decision Date 03/26/2021
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
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