Device Classification Name |
wound dressing with animal-derived material(s)
|
510(k) Number |
K152721 |
Device Name |
Cytal Wound Matrix |
Applicant |
ACELL, INC |
6640 ELI WHITNEY DR |
COLUMBIA,
MD
21046
|
|
Applicant Contact |
THOMAS GILBERT |
Correspondent |
ACELL, INC |
6640 ELI WHITNEY DR |
COLUMBIA,
MD
21046
|
|
Correspondent Contact |
THOMAS GILBERT |
Classification Product Code |
|
Date Received | 09/21/2015 |
Decision Date | 12/08/2015 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|