| Device Classification Name |
Diaphragm, Contraceptive (And Accessories)
|
|---|
| 510(k) Number |
K063223 |
|---|
| Device Name |
MILEX CONTRACEPTIVE DIAPHRAGM, OMNIFLEX DIAPHRAGMS, ARCING DIAPHRAGMS, WIDESEAL DIAPHRAGMS |
|---|
| Applicant |
| CooperSurgical, Inc. |
| 543 Long Hill Ave. |
|
Shelton,
CT
06484
|
|
| Applicant Contact |
JOSEPH AZARY |
| Correspondent |
| CooperSurgical, Inc. |
| 543 Long Hill Ave. |
|
Shelton,
CT
06484
|
|
| Correspondent Contact |
JOSEPH AZARY |
| Regulation Number | 884.5350 |
|---|
| Classification Product Code |
|
|---|
| Date Received | 10/24/2006 |
|---|
| Decision Date | 01/23/2008 |
|---|
| 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
|
|---|
Predetermined Change
Control Plan Authorized |
No
|
|---|
| Recalls |
CDRH Recalls
|
|---|