Device Classification Name |
needle, pneumoperitoneum, simple
|
510(k) Number |
K910855 |
Device Name |
ENDOPATH VERESS NEEDLE |
Applicant |
SYMBIOSIS CORP. |
5801 MIAMI LAKES DR. |
MIAMI LAKES,
FL
33014
|
|
Applicant Contact |
KEVIN SMITH |
Correspondent |
SYMBIOSIS CORP. |
5801 MIAMI LAKES DR. |
MIAMI LAKES,
FL
33014
|
|
Correspondent Contact |
KEVIN SMITH |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 02/28/1991 |
Decision Date | 04/18/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|