Device Classification Name |
laparoscope, general & plastic surgery
|
510(k) Number |
K925041 |
Device Name |
MCKERNAN ATRAUMATIC FORCEPS |
Applicant |
ASLAN MEDICAL TECHNOLOGIES, LTD. |
100 HEGENBERGER RD. |
SUITE 210 |
OAKLAND,
CA
94621
|
|
Applicant Contact |
DOUGLAS DONALDSON |
Correspondent |
ASLAN MEDICAL TECHNOLOGIES, LTD. |
100 HEGENBERGER RD. |
SUITE 210 |
OAKLAND,
CA
94621
|
|
Correspondent Contact |
DOUGLAS DONALDSON |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 10/05/1992 |
Decision Date | 11/25/1992 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|