Device Classification Name |
Insufflator, Laparoscopic
|
510(k) Number |
K170784 |
Device Name |
PNEUMOCLEAR |
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 | 03/15/2017 |
Decision Date | 05/15/2017 |
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
|
Recalls |
CDRH Recalls
|
|
|