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 |