Device Classification Name |
Hysteroscope (And Accessories)
|
510(k) Number |
K974297 |
Device Name |
GALILEO DISPOSABLE HYSTEROSCOPES |
Applicant |
NETOPTIX CORP. |
49 PLAIN ST. |
NORTH ATTLEBORO,,
MA
02760
|
|
Applicant Contact |
MARY MCNAMARA-CULLINANE |
Correspondent |
NETOPTIX CORP. |
49 PLAIN ST. |
NORTH ATTLEBORO,,
MA
02760
|
|
Correspondent Contact |
MARY MCNAMARA-CULLINANE |
Regulation Number | 884.1690
|
Classification Product Code |
|
Date Received | 11/17/1997 |
Decision Date | 02/13/1998 |
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
|
|
|