Device Classification Name |
insufflator, laparoscopic
|
510(k) Number |
K170799 |
Device Name |
AP 50/30 Insufflator with Insuflow Port |
Applicant |
LEXION Medical LLC |
545 Atwater Circle |
St Paul,
MN
55103
|
|
Applicant Contact |
Bernard Horwath |
Correspondent |
HRG |
4486 Timberline Ct |
Vadnais Heights,
MN
55127
|
|
Correspondent Contact |
Bernard Horwath |
Regulation Number | 884.1730
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 03/17/2017 |
Decision Date | 11/14/2017 |
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
|
|
|