Device Classification Name |
clip, implantable
|
510(k) Number |
K993424 |
Device Name |
THE TRUE Y CLIP, THE MICRO Y CLIP, THE LAPAROSCOPIC Y CLIP |
Applicant |
Y-CLIP ASSOCIATES |
116 DEFENSE HIGHWAY |
ANNAPOLIS,
MD
21401
|
|
Applicant Contact |
GEORGE YU |
Correspondent |
Y-CLIP ASSOCIATES |
116 DEFENSE HIGHWAY |
ANNAPOLIS,
MD
21401
|
|
Correspondent Contact |
GEORGE YU |
Regulation Number | 878.4300
|
Classification Product Code |
|
Date Received | 10/12/1999 |
Decision Date | 12/23/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|