Device Classification Name |
Condom
|
510(k) Number |
K955648 |
Device Name |
K-Y PERSONAL LUBRICANT |
Applicant |
ORTHO PHARMACEUTICAL CORP. |
RT. 202 |
RARITAN,
NJ
08869 -0602
|
|
Applicant Contact |
DIANE HERRON |
Correspondent |
ORTHO PHARMACEUTICAL CORP. |
RT. 202 |
RARITAN,
NJ
08869 -0602
|
|
Correspondent Contact |
DIANE HERRON |
Regulation Number | 884.5300
|
Classification Product Code |
|
Date Received | 12/12/1995 |
Decision Date | 06/21/1996 |
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
|
|
|