K-Y BRAND INTRIGUE INTENSE WARMING SENSATION


Device Classification Name

lubricant, personal

510(k) Number K072360
Device Name K-Y BRAND INTRIGUE INTENSE WARMING SENSATION
Applicant
MCNEIL-PPC, INC.
199 grandview road
skillman, 
NJ 
08558

Applicant Contact nader fotouhu, ph.d.
Correspondent
MCNEIL-PPC, INC.
199 grandview road
skillman, 
NJ 
08558

Correspodent Contact nader fotouhu, ph.d.
Regulation Number 884.5300
Classification Product Code
NUC  
Date Received 08/22/2007
Decision Date 12/12/2007
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