The following data is part of a premarket notification filed by Hi-tech Pharmacal, Inc. with the FDA for Nasal Ease Allergy Blocker.
Device ID | K132520 |
510k Number | K132520 |
Device Name: | NASAL EASE ALLERGY BLOCKER |
Classification | Cream, Nasal, Topical, Mechanical Allergen Particle Barrier |
Applicant | HI-TECH PHARMACAL, INC. 369 BAYVIEW AVE Amityville, NY 11701 |
Contact | Gary April |
Correspondent | Gary April HI-TECH PHARMACAL, INC. 369 BAYVIEW AVE Amityville, NY 11701 |
Product Code | NUP |
CFR Regulation Number | 880.5045 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-08-12 |
Decision Date | 2013-12-31 |
Summary: | summary |