Device Classification Name |
Lubricant, Personal
|
510(k) Number |
K040340 |
Device Name |
K-Y BRAND WARMING ULTRAGEL PERSONAL LUBRICANT |
Applicant |
PERSONAL PRODUCTS COMPANY, DIV. OF MCNEIL-PPC, INC |
199 GRANDVIEW RD. |
SKILLMAN,
NJ
08558 -9418
|
|
Applicant Contact |
MARYLOU (PANICO) CARLSON |
Correspondent |
PERSONAL PRODUCTS COMPANY, DIV. OF MCNEIL-PPC, INC |
199 GRANDVIEW RD. |
SKILLMAN,
NJ
08558 -9418
|
|
Correspondent Contact |
MARYLOU (PANICO) CARLSON |
Regulation Number | 884.5300
|
Classification Product Code |
|
Date Received | 02/11/2004 |
Decision Date | 04/28/2004 |
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
|
|
|