Device Classification Name |
Insufflator, Laparoscopic
|
510(k) Number |
K030837 |
Device Name |
40 L HIGH FLOW INSUFFLATOR F108 |
Applicant |
W.O.M. WORLD OF MEDICINE AG |
368 NORTH ASAPH STREET |
ALEXANDRIA,
VA
22314
|
|
Applicant Contact |
SUSANNE RAAB |
Correspondent |
W.O.M. WORLD OF MEDICINE AG |
368 NORTH ASAPH STREET |
ALEXANDRIA,
VA
22314
|
|
Correspondent Contact |
SUSANNE RAAB |
Regulation Number | 884.1730
|
Classification Product Code |
|
Date Received | 03/17/2003 |
Decision Date | 02/05/2004 |
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
|
|
|