Device Classification Name |
Lubricant, Personal
|
510(k) Number |
K072421 |
Device Name |
K-Y BRAND YOURS+MINE |
Applicant |
MCNEIL-PPC, INC. |
199 Grandview Road |
Skillman,
NJ
08558
|
|
Applicant Contact |
NADER FOTOUHI |
Correspondent |
MCNEIL-PPC, INC. |
199 Grandview Road |
Skillman,
NJ
08558
|
|
Correspondent Contact |
NADER FOTOUHI |
Regulation Number | 884.5300
|
Classification Product Code |
|
Date Received | 08/28/2007 |
Decision Date | 03/06/2008 |
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 |
Yes
|
|
|