FDA 510(k) Application Details - K132520

Device Classification Name Cream, Nasal, Topical, Mechanical Allergen Particle Barrier

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510(K) Number K132520
Device Name Cream, Nasal, Topical, Mechanical Allergen Particle Barrier
Applicant HI-TECH PHARMACAL, INC.
369 BAYVIEW AVE
AMITYVILLE, NY 11701 US
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Contact GARY APRIL
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Regulation Number 880.5045

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Classification Product Code NUP
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Date Received 08/12/2013
Decision Date 12/31/2013
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee EN - Ear, Nose, & Throat
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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