ONE PERSONAL LUBRICANT (WATER BASED)


Device Classification Name

lubricant, personal

510(k) Number K110691
Device Name ONE PERSONAL LUBRICANT (WATER BASED)
Applicant
ONE
12 channel street
boston, 
MA 
02210

Applicant Contact sharon pietila
Correspondent
ONE
12 channel street
boston, 
MA 
02210

Correspodent Contact sharon pietila
Regulation Number 884.5300
Classification Product Code
NUC  
Date Received 03/11/2011
Decision Date 02/01/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Obstetrics/Gynecology

510k Review Panel

Obstetrics/Gynecology

summary

summary

Type Abbreviated
Reviewed by Third Party No

Combination Product

No