Device Classification Name |
insufflator, hysteroscopic
|
510(k) Number |
K924523 |
Device Name |
HYS-SURGIFLATOR |
Applicant |
W.O.M. WORLD OF MEDICINE, GMBH |
C/O QUALITIVITY |
8536 CALLE TIOGA |
TUCSON,
AZ
85704 -6508
|
|
Applicant Contact |
OWEN B LAMB |
Correspondent |
W.O.M. WORLD OF MEDICINE, GMBH |
C/O QUALITIVITY |
8536 CALLE TIOGA |
TUCSON,
AZ
85704 -6508
|
|
Correspondent Contact |
OWEN B LAMB |
Regulation Number | 884.1700
|
Classification Product Code |
|
Date Received | 09/08/1992 |
Decision Date | 04/11/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|