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 |