Device Classification Name |
insufflator, laparoscopic
|
510(k) Number |
K143404 |
Device Name |
SurgiQuest AirSeal iFS System |
Applicant |
SURGIQUEST, INC. |
333 Quarry Rd |
Milford,
CT
06460
|
|
Applicant Contact |
Daniel Donovan |
Correspondent |
SURGIQUEST, INC. |
333 Quarry Rd |
Milford,
CT
06460
|
|
Correspondent Contact |
Daniel Donovan |
Regulation Number | 884.1730
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 11/28/2014 |
Decision Date | 03/20/2015 |
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
|
|
|