Device Classification Name |
Splint, Intranasal Septal
|
510(k) Number |
K113585 |
Device Name |
NASAL/EPISTAXIS PACK |
Applicant |
COGENT THERAPEUTICS, LLC |
3637 BERNAL AVENUE |
PLEASANTON,
CA
94566
|
|
Applicant Contact |
ANNE WORDEN |
Correspondent |
COGENT THERAPEUTICS, LLC |
3637 BERNAL AVENUE |
PLEASANTON,
CA
94566
|
|
Correspondent Contact |
ANNE WORDEN |
Regulation Number | 874.4780
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 12/05/2011 |
Decision Date | 04/25/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|