ME AGAIN(R) LONG LASTING VAGINAL MOISTURIZER, VH ESSENTIALS (R) LONG LASTING VAGINAL MOISTURIZER


Device Classification Name

lubricant, personal

510(k) Number K112217
Device Name ME AGAIN(R) LONG LASTING VAGINAL MOISTURIZER, VH ESSENTIALS (R) LONG LASTING VAGINAL MOISTURIZER
Applicant
POLICHEM S.A.
1 pharmacal way
jackson, 
WI 
53037

Applicant Contact john nygaard
Correspondent
POLICHEM S.A.
1 pharmacal way
jackson, 
WI 
53037

Correspodent Contact john nygaard
Regulation Number 884.5300
Classification Product Code
NUC  
Date Received 08/02/2011
Decision Date 10/16/2012
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