Device Classification Name |
laparoscope, general & plastic surgery
|
510(k) Number |
K152848 |
Device Name |
AUTOLAP SYSTEM |
Applicant |
M.S.T Medical Surgery Technologies LTD |
Kochav Yokneam Building, floor 5, POB 685 |
Yokneam llit,
IL
2069200
|
|
Applicant Contact |
Tami Harel |
Correspondent |
HOGAN LOVELLS US LLP |
555 THIRTEENTH STREET NW |
WASHINGTON,
DC
20004
|
|
Correspondent Contact |
John J Smith |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 09/29/2015 |
Decision Date | 11/17/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|