Device Classification Name |
Dressing, Wound, Drug
|
510(k) Number |
K152055 |
Device Name |
Ceramax Skin Barrier Cream |
Applicant |
OCULUS INNOVATIVE SCIENCES |
1129 N. MCDOWELL BOULEVARD |
PETALUMA,
CA
94954
|
|
Applicant Contact |
BRIAN W. MARTIN |
Correspondent |
OCULUS INNOVATIVE SCIENCES |
1129 N. MCDOWELL BOULEVARD |
PETALUMA,
CA
94954
|
|
Correspondent Contact |
BRIAN W. MARTIN |
Classification Product Code |
|
Date Received | 07/24/2015 |
Decision Date | 11/23/2015 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
Yes
|
Recalls |
CDRH Recalls
|
|
|