Device Classification Name |
laparoscope, gynecologic (and accessories)
|
510(k) Number |
K163320 |
Device Name |
LAP-Pump PP110 |
Applicant |
W.O.M. WORLD OF MEDICINE GMBH |
SALZUFER 8 |
Berlin,
DE
10587
|
|
Applicant Contact |
Soeren Markworth |
Correspondent |
W.O.M. WORLD OF MEDICINE GMBH |
SALZUFER 8 |
Berlin,
DE
10587
|
|
Correspondent Contact |
Soeren Markworth |
Regulation Number | 884.1720
|
Classification Product Code |
|
Date Received | 11/23/2016 |
Decision Date | 03/21/2017 |
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
|
|
|