Device Classification Name |
insufflator, laparoscopic
|
510(k) Number |
K111441 |
Device Name |
UNIMAX VERESS NEEDLE |
Applicant |
UNIMAX MEDICAL SYSTEMS, INC. |
NO. 45, MINSHEN RD. |
DANSHUI TOWN |
TAIPEI COUNTY,
TW
251
|
|
Applicant Contact |
MICHAEL LEE |
Correspondent |
UNIMAX MEDICAL SYSTEMS, INC. |
NO. 45, MINSHEN RD. |
DANSHUI TOWN |
TAIPEI COUNTY,
TW
251
|
|
Correspondent Contact |
MICHAEL LEE |
Regulation Number | 884.1730
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 05/24/2011 |
Decision Date | 08/19/2011 |
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
|
|
|