Device Classification Name |
cream, nasal, topical, mechanical allergen particle barrier
|
510(k) Number |
K053625 |
Device Name |
NASALGUARD |
Applicant |
TRUTEK CORP |
80 WEST END AVE. |
SOMERVILLE,
NJ
08876
|
|
Applicant Contact |
ASHOK WAHL |
Correspondent |
TRUTEK CORP |
80 WEST END AVE. |
SOMERVILLE,
NJ
08876
|
|
Correspondent Contact |
ASHOK WAHL |
Regulation Number | 880.5045
|
Classification Product Code |
|
Date Received | 12/28/2005 |
Decision Date | 02/22/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
Ear Nose & Throat
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|