Device Classification Name |
Cream, Nasal, Topical, Mechanical Allergen Particle Barrier
More FDA Info for this Device |
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
Other 510(k) Applications for this Company
|
Contact |
GARY APRIL
Other 510(k) Applications for this Contact |
Regulation Number |
880.5045
More FDA Info for this Regulation Number |
Classification Product Code |
NUP
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
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 |
|