Device Classification Name |
insufflator, laparoscopic
|
510(k) Number |
K142700 |
Device Name |
InsufflatOR Needle |
Applicant |
GYNETECH PTY. LTD. |
Unit 7, 6-8 Macquarie Drive |
Thomastown,
AU
3095
|
|
Applicant Contact |
Kevin MacDonald |
Correspondent |
MacDonald Consulting |
229 Marvilla Circle |
Pacifica,
CA
94044
|
|
Correspondent Contact |
Kevin MacDonald |
Regulation Number | 884.1730
|
Classification Product Code |
|
Date Received | 09/22/2014 |
Decision Date | 12/19/2014 |
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
|
|
|