Device Classification Name |
device, engorgement, clitoral
|
510(k) Number |
K001576 |
Device Name |
EVA -VACUUM ASSIST DEVICE FOR CLITORAL THERAPY |
Applicant |
PROSURG, INC. |
2193 TRADE ZONE BLVD. |
SAN JOSE,
CA
95131
|
|
Applicant Contact |
LEE BUI |
Correspondent |
PROSURG, INC. |
2193 TRADE ZONE BLVD. |
SAN JOSE,
CA
95131
|
|
Correspondent Contact |
LEE BUI |
Regulation Number | 884.5970
|
Classification Product Code |
|
Date Received | 05/22/2000 |
Decision Date | 12/28/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|