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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 K132520
Device Name NASAL EASE ALLERGY BLOCKER
Applicant
HI-TECH PHARMACAL, INC.
369 BAYVIEW AVE
AMITYVILLE,  NY  11701
Applicant Contact GARY APRIL
Correspondent
HI-TECH PHARMACAL, INC.
369 BAYVIEW AVE
AMITYVILLE,  NY  11701
Correspondent Contact GARY APRIL
Regulation Number880.5045
Classification Product Code
NUP  
Date Received08/12/2013
Decision Date 12/31/2013
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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