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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name lubricant, personal, gamete, fertilization, and embryo compatible
510(k) Number K141132
Device Name ASTROGLIDE TTC FERTILITY FRIENDLY PERSONAL LUBRICANT
Applicant
BIOFILM, INC.
3225 Executive Rdg
VISTA,  CA  92081
Applicant Contact Sherry Castello
Correspondent
BIOFILM, INC.
3225 Executive Rdg
VISTA,  CA  92081
Correspondent Contact Sherry Castello
Regulation Number884.5300
Classification Product Code
PEB  
Date Received05/01/2014
Decision Date 01/09/2015
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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