Device Classification Name |
insufflator, hysteroscopic
|
510(k) Number |
K933847 |
Device Name |
HYS-SURGIFLATOR VP |
Applicant |
W.O.M. WORLD OF MEDICINE, GMBH |
1300 I STREET, N.W. |
SUITE 900 WEST |
WASHIGNTON,
DC
20005 -3306
|
|
Applicant Contact |
E. KEEFER |
Correspondent |
W.O.M. WORLD OF MEDICINE, GMBH |
1300 I STREET, N.W. |
SUITE 900 WEST |
WASHIGNTON,
DC
20005 -3306
|
|
Correspondent Contact |
E. KEEFER |
Regulation Number | 884.1700
|
Classification Product Code |
|
Date Received | 08/06/1993 |
Decision Date | 08/15/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|