Device Classification Name |
cannula, manipulator/injector, uterine
|
510(k) Number |
K023051 |
Device Name |
INTRAUTERINE DELIVERY SYSTEM - INJECTOR |
Applicant |
PROSURG, INC. |
2193 TRADE ZONE BLVD. |
SAN JOSE,
CA
95131
|
|
Applicant Contact |
ASHVIN DESAI |
Correspondent |
PROSURG, INC. |
2193 TRADE ZONE BLVD. |
SAN JOSE,
CA
95131
|
|
Correspondent Contact |
ASHVIN DESAI |
Regulation Number | 884.4530
|
Classification Product Code |
|
Date Received | 09/13/2002 |
Decision Date | 12/12/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|