Device Classification Name |
retention device, suture
|
510(k) Number |
K904435 |
Device Name |
VENTROFIL TENSION RELIEF SUTURE SET |
Applicant |
AESCULAP, INC. |
875 STANTON RD. |
BURLINGAME,
CA
94010
|
|
Applicant Contact |
ROBIN BUSH |
Correspondent |
AESCULAP, INC. |
875 STANTON RD. |
BURLINGAME,
CA
94010
|
|
Correspondent Contact |
ROBIN BUSH |
Regulation Number | 878.4930
|
Classification Product Code |
|
Date Received | 09/28/1990 |
Decision Date | 08/29/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|