Device Classification Name |
Insufflator, Laparoscopic
|
510(k) Number |
K063367 |
FOIA Releasable 510(k) |
K063367
|
Device Name |
45L CORE INSUFFLATOR, MODEL F114 |
Applicant |
W.O.M. WORLD OF MEDICINE AG |
1480 CAMBRIDGE STREET |
CAMBRIDGE,
MA
02139
|
|
Applicant Contact |
SUSANNE RAAB |
Correspondent |
W.O.M. WORLD OF MEDICINE AG |
1480 CAMBRIDGE STREET |
CAMBRIDGE,
MA
02139
|
|
Correspondent Contact |
SUSANNE RAAB |
Regulation Number | 884.1730
|
Classification Product Code |
|
Date Received | 11/07/2006 |
Decision Date | 05/23/2007 |
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
|
|
|