Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
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
Correspondent Contact ROBERT DE ARMOND
Regulation Number884.5300
Classification Product Code
NUC  
Date Received09/19/2007
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
-
-