The following data is part of a premarket notification filed by Trutek Corp with the FDA for Nasalguard.
| Device ID | K053625 |
| 510k Number | K053625 |
| Device Name: | NASALGUARD |
| Classification | Cream, Nasal, Topical, Mechanical Allergen Particle Barrier |
| Applicant | TRUTEK CORP 80 WEST END AVE. Somerville, NJ 08876 |
| Contact | Ashok Wahl |
| Correspondent | Ashok Wahl TRUTEK CORP 80 WEST END AVE. Somerville, NJ 08876 |
| Product Code | NUP |
| CFR Regulation Number | 880.5045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-12-28 |
| Decision Date | 2006-02-22 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() NASALGUARD 76483129 2758780 Live/Registered |
Trutek Corp. 2003-01-17 |
![]() NASALGUARD 75531673 not registered Dead/Abandoned |
TRUTEK CORP. 1998-08-05 |