Device Classification Name |
condom, synthetic
|
510(k) Number |
K971590 |
Device Name |
TACTYLON CONDOM |
Applicant |
SENSICON CORP. |
2595 COMMERCE WAY |
VISTA,
CA
92083
|
|
Applicant Contact |
JORGE HAIDER |
Correspondent |
SENSICON CORP. |
2595 COMMERCE WAY |
VISTA,
CA
92083
|
|
Correspondent Contact |
JORGE HAIDER |
Regulation Number | 884.5300
|
Classification Product Code |
|
Date Received | 05/01/1997 |
Decision Date | 10/07/1997 |
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
|
|
|