Device Classification Name |
Insufflator, Laparoscopic
|
510(k) Number |
K153513 |
Device Name |
Insufflator 50L FM134 |
Applicant |
W.O.M WORLD OF MEDICINE GMBH |
SALZUFER 8 |
BERLIN,
DE
10587
|
|
Applicant Contact |
Soeren Markworth |
Correspondent |
Susanne Raab |
1480 Cambridge Street |
Cambridge,
MA
02139
|
|
Correspondent Contact |
SUSANNE RAAB |
Regulation Number | 884.1730
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 12/07/2015 |
Decision Date | 03/04/2016 |
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
|
|
|