Device Classification Name |
Splint, Intranasal Septal
|
510(k) Number |
K172179 |
Device Name |
Chitogel Endoscopic Sinus Surgery Kit |
Applicant |
Chitogel Ltd |
139 Moray Place |
Dunedin,
NZ
9016
|
|
Applicant Contact |
Caty Spencer |
Correspondent |
Regulatory Strategies, Inc |
3924 Cascade Beach Road |
Lutsen,
MN
55612
|
|
Correspondent Contact |
Gregory Mathison |
Regulation Number | 874.4780
|
Classification Product Code |
|
Date Received | 07/19/2017 |
Decision Date | 10/17/2017 |
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
|
|
|