Device Classification Name |
pessary, vaginal
|
510(k) Number |
K031463 |
Device Name |
MARINA MEDICAL SILICONE PESSARY |
Applicant |
MARINA MEDICAL INSTRUMENTS, INC. |
1308 MORNINGSIDE PARK DR. |
ALPHARETTA,
GA
30022
|
|
Applicant Contact |
JAY MANSOUR |
Correspondent |
MARINA MEDICAL INSTRUMENTS, INC. |
1308 MORNINGSIDE PARK DR. |
ALPHARETTA,
GA
30022
|
|
Correspondent Contact |
JAY MANSOUR |
Regulation Number | 884.3575
|
Classification Product Code |
|
Date Received | 05/08/2003 |
Decision Date | 11/18/2003 |
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
|
|
|