Device Classification Name |
Laparoscopic Single Port Access Device
|
510(k) Number |
K121309 |
Device Name |
ASC QUADPORT + LAPAROSCOPIC ACCESS DEVICE |
Applicant |
ADVANCED SURGICAL CONCEPTS |
355 THIRTEENTH STREET, NW |
COLUMBIA SQUARE |
WASHINGTON,
DC
20004
|
|
Applicant Contact |
JONATHAN KAHAN |
Correspondent |
ADVANCED SURGICAL CONCEPTS |
355 THIRTEENTH STREET, NW |
COLUMBIA SQUARE |
WASHINGTON,
DC
20004
|
|
Correspondent Contact |
JONATHAN KAHAN |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 05/01/2012 |
Decision Date | 09/06/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|