Device Classification Name |
insufflator, laparoscopic
|
510(k) Number |
K981859 |
Device Name |
SURGIFLATOR-20 ECU |
Applicant |
W.O.M. WORLD OF MEDICINE, GMBH |
1775 I STREET, N.W. |
WASHINGTON,
DC
20006 -2401
|
|
Applicant Contact |
ROBERT P REZNICK |
Correspondent |
W.O.M. WORLD OF MEDICINE, GMBH |
1775 I STREET, N.W. |
WASHINGTON,
DC
20006 -2401
|
|
Correspondent Contact |
ROBERT P REZNICK |
Regulation Number | 884.1730
|
Classification Product Code |
|
Date Received | 05/27/1998 |
Decision Date | 06/26/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|