Device Classification Name |
condom, synthetic
|
510(k) Number |
K962816 |
Device Name |
SPERM PREPARATION MEDIA |
Applicant |
GENX INTL., INC. |
339 BARTLETT DR. |
MADISON,
CT
06443
|
|
Applicant Contact |
MICHAEL D CECCHI |
Correspondent |
GENX INTL., INC. |
339 BARTLETT DR. |
MADISON,
CT
06443
|
|
Correspondent Contact |
MICHAEL D CECCHI |
Regulation Number | 884.5300
|
Classification Product Code |
|
Date Received | 07/19/1996 |
Decision Date | 11/26/1996 |
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
|
|
|