Device Classification Name |
Pneumoperitoneum Needle
|
510(k) Number |
K943624 |
Device Name |
ELMED PNEUMOPERITONEUM NEEDLES |
Applicant |
HENKE-SASS WOLF, GMBH. |
POSTFACH 2459 |
TUTTLINGEN,
DE
78507
|
|
Applicant Contact |
RANDAL CHINNOCK |
Correspondent |
HENKE-SASS WOLF, GMBH. |
POSTFACH 2459 |
TUTTLINGEN,
DE
78507
|
|
Correspondent Contact |
RANDAL CHINNOCK |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 07/26/1994 |
Decision Date | 08/10/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|