Device Classification Name |
Laparoscope, General & Plastic Surgery
|
510(k) Number |
K924011 |
Device Name |
ORIGIN BLUNT TIP SURGICAL TROCAR |
Applicant |
ORIGIN MEDSYSTEMS, INC. |
135 CONSTITUTION DR. |
MENLO PARK,
CA
94025
|
|
Applicant Contact |
ALBERT K CHIN |
Correspondent |
ORIGIN MEDSYSTEMS, INC. |
135 CONSTITUTION DR. |
MENLO PARK,
CA
94025
|
|
Correspondent Contact |
ALBERT K CHIN |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 08/10/1992 |
Decision Date | 07/09/1993 |
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
|
Recalls |
CDRH Recalls
|
|
|