Device Classification Name |
Insufflator, Laparoscopic
|
510(k) Number |
K172835 |
Device Name |
GRI-Alleset Veress Needle |
Applicant |
GRI Medical and Electronic Technology Co., Ltd. |
105 Honggao Road, Xiuzhou Industry Zone |
Jiaxing,
CN
314031
|
|
Applicant Contact |
Martin Paugh |
Correspondent |
Sharon Marrow |
2907 Cherry Branch Drive |
Knoxville,
TN
37948
|
|
Correspondent Contact |
Sharon Marrow |
Regulation Number | 884.1730
|
Classification Product Code |
|
Date Received | 09/19/2017 |
Decision Date | 06/11/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|