GLYCERIN & PARABEN FREE ASTROGLIDE


Device Classification Name

lubricant, personal

510(k) Number K072647
Device Name GLYCERIN & PARABEN FREE ASTROGLIDE
Applicant
BIOFILM, INC.
3225 executive ridge
vista, 
CA 
92081

Applicant Contact robert de armond
Correspondent
BIOFILM, INC.
3225 executive ridge
vista, 
CA 
92081

Correspodent Contact robert de armond
Regulation Number 884.5300
Classification Product Code
NUC  
Date Received 09/19/2007
Decision Date 01/25/2008
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