K-Y BRAND YOURS+MINE


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

Correspodent Contact nader fotouhi
Regulation Number 884.5300
Classification Product Code
NUC  
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