Device Classification Name |
wound dressing with animal-derived material(s)
|
510(k) Number |
K173223 |
Device Name |
ologen Collagen Matrix |
Applicant |
Aeon Astron Europe B.V. |
J.H. Oortweg 19 |
Leiden,
NL
2333 CH
|
|
Applicant Contact |
Horng Ji Lai |
Correspondent |
Aeon Astron Europe B.V. |
J.H. Oortweg 19 |
Leiden,
NL
2333 CH
|
|
Correspondent Contact |
Horng Ji Lai |
Classification Product Code |
|
Date Received | 10/03/2017 |
Decision Date | 03/02/2018 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|