Device Classification Name |
Clip, Implantable
|
510(k) Number |
K953258 |
Device Name |
TITANIUM HEMOSTATIC CLIP |
Applicant |
INTRAMED LABORATORIES, INC. |
11100 ROSELLE ST. |
SAN DIEGO,
CA
92121
|
|
Applicant Contact |
R. ALDEN KAY |
Correspondent |
INTRAMED LABORATORIES, INC. |
11100 ROSELLE ST. |
SAN DIEGO,
CA
92121
|
|
Correspondent Contact |
R. ALDEN KAY |
Regulation Number | 878.4300
|
Classification Product Code |
|
Date Received | 07/12/1995 |
Decision Date | 01/05/1996 |
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
|
|
|