Device Classification Name |
Laparoscopy Kit
|
510(k) Number |
K950924 |
Device Name |
ASLAN KNOT PUSHER |
Applicant |
ASLAN MEDICAL TECHNOLOGIES, LTD. |
6376 QUAIL RUN DR. |
KALAMAZOO,
MI
49009
|
|
Applicant Contact |
THOMAS J HOOGEBOOM |
Correspondent |
ASLAN MEDICAL TECHNOLOGIES, LTD. |
6376 QUAIL RUN DR. |
KALAMAZOO,
MI
49009
|
|
Correspondent Contact |
THOMAS J HOOGEBOOM |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 03/01/1995 |
Decision Date | 03/14/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|