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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name condom
510(k) Number K041432
Device Name ASTROGLIDE BRAND WARMING LIQUID PERSONAL LUBRICANT
Applicant
BIOFILM, INC.
3225 EXECUTIVE RIDGE
VISTA,  CA  92081
Applicant Contact ROBERT L DE ARMOND
Correspondent
BIOFILM, INC.
3225 EXECUTIVE RIDGE
VISTA,  CA  92081
Correspondent Contact ROBERT L DE ARMOND
Regulation Number884.5300
Classification Product Code
HIS  
Date Received05/28/2004
Decision Date 11/30/2004
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
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