ASTROGLIDE TTC FERTILITY FRIENDLY PERSONAL LUBRICANT— 510(k) K141132

Name: FDA 510(k) clearance K141132
Creator: U.S. Food and Drug Administration
Published: 2015-01-09

Substantially Equivalent

Biofilm, Inc.

FDA 510(k) clearance K141132 for ASTROGLIDE TTC FERTILITY FRIENDLY PERSONAL LUBRICANT, Substantially Equivalent on 2015-01-09. Applicant: Biofilm, Inc.. Device class: 2.

Clearance details

Applicant: Biofilm, Inc.
Product code: Code PEB
Device class: Class 2
Regulation: 21 CFR 884.5300
Advisory panel: Obstetrics/Gynecology
Date received: 2014-05-01
Decision date: 2015-01-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Vista, CA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.