DUREX PLAY TINGLING AQUEOUS BASED LUBRICANT


Device Classification Name

lubricant, personal

510(k) Number K072236
Device Name DUREX PLAY TINGLING AQUEOUS BASED LUBRICANT
Applicant
SSL AMERICAS
3585 engineering dr.
norcross, 
GA 
30092

Applicant Contact chris robinson
Correspondent
SSL AMERICAS
3585 engineering dr.
norcross, 
GA 
30092

Correspodent Contact chris robinson
Regulation Number 884.5300
Classification Product Code
NUC  
Date Received 08/10/2007
Decision Date 05/07/2008
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

No