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 K200239
Device Name Astroglide Organix Gel
Applicant
BioFilm Inc.
3225 Executive Ridge
Vista,  CA  92081
Applicant Contact Richard Hines
Correspondent
BioFilm Inc.
3225 Executive Ridge
Vista,  CA  92081
Correspondent Contact Richard Hines
Regulation Number884.5300
Classification Product Code
NUC  
Date Received01/31/2020
Decision Date 11/13/2020
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
-
-