AQUA LUBE


Device Classification Name

lubricant, personal

510(k) Number K110325
Device Name AQUA LUBE
Applicant
MAYER LABORATORIES, INC.
1950 addison street, suite 101
berkely, 
CA 
94704 -1182

Applicant Contact david p mayer
Correspondent
MAYER LABORATORIES, INC.
1950 addison street, suite 101
berkely, 
CA 
94704 -1182

Correspodent Contact david p mayer
Regulation Number 884.5300
Classification Product Code
NUC  
Date Received 02/03/2011
Decision Date 12/08/2011
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