Device Classification Name |
Insufflator, Hysteroscopic
|
510(k) Number |
K922632 |
Device Name |
WOM HYSTEROFLATOR OP |
Applicant |
W.O.M. GMBH |
PASCALSTRABE 11 |
BERLIN,
DE
D-10587
|
|
Applicant Contact |
OWEN LAMB |
Correspondent |
W.O.M. GMBH |
PASCALSTRABE 11 |
BERLIN,
DE
D-10587
|
|
Correspondent Contact |
OWEN LAMB |
Regulation Number | 884.1700
|
Classification Product Code |
|
Date Received | 03/04/1992 |
Decision Date | 03/25/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|