Device Classification Name |
drainage catheter with antibiotic
|
510(k) Number |
K063245 |
Device Name |
ELUTIA COATED CLOSED SURGICAL WOUND DRAIN |
Applicant |
BACTERIN INTERNATIONAL INC. |
543 LONG HILL AVENUE |
SHELTON,
CT
06484
|
|
Applicant Contact |
JOSEPH M AZARY |
Correspondent |
BACTERIN INTERNATIONAL INC. |
543 LONG HILL AVENUE |
SHELTON,
CT
06484
|
|
Correspondent Contact |
JOSEPH M AZARY |
Regulation Number | 878.4780
|
Classification Product Code |
|
Date Received | 10/26/2006 |
Decision Date | 11/28/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
Yes
|
Recalls |
CDRH Recalls
|