Device Classification Name |
Dressing, Wound, Drug
|
510(k) Number |
K190342 |
Device Name |
BIAFINE Topical Cream |
Applicant |
Bausch Health Americas Incorporated |
1400 N. Goodman St. 14609 USA |
Rochester,
NY
14609
|
|
Applicant Contact |
Marci Halevi |
Correspondent |
Bausch Health Americas Incorporated |
1400 N. Goodman St. 14609 USA |
Rochester,
NY
14609
|
|
Correspondent Contact |
Marci Halevi |
Classification Product Code |
|
Date Received | 02/14/2019 |
Decision Date | 10/18/2019 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
Yes
|
|
|