K-Y BRAND LIQUIBEADS


Device Classification Name

lubricant, personal

510(k) Number K122061
Device Name K-Y BRAND LIQUIBEADS
Applicant
JOHNSON & JOHNSON HEALTHCARE PRODUCTS
185 tabor road
morris plains, 
NJ 
07950

Applicant Contact lorna-jane bremer
Correspondent
JOHNSON & JOHNSON HEALTHCARE PRODUCTS
185 tabor road
morris plains, 
NJ 
07950

Correspodent Contact lorna-jane bremer
Regulation Number 884.5300
Classification Product Code
NUC  
Date Received 07/13/2012
Decision Date 11/08/2013
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