Device Classification Name |
insufflator, laparoscopic
|
510(k) Number |
K973432 |
Device Name |
SURGIFLATOR-30 |
Applicant |
W.O.M. WORLD OF MEDICINE, GMBH |
PASCALSTRABE 11 |
BERLIN,
DE
D-10587
|
|
Applicant Contact |
ROBERT P REZNICK |
Correspondent |
W.O.M. WORLD OF MEDICINE, GMBH |
PASCALSTRABE 11 |
BERLIN,
DE
D-10587
|
|
Correspondent Contact |
ROBERT P REZNICK |
Regulation Number | 884.1730
|
Classification Product Code |
|
Date Received | 09/10/1997 |
Decision Date | 12/09/1997 |
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
|
|
|