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 K221036
Device Name Astroglide Warming
Applicant
Biofilm, Inc.
3225 Executive Ridge
Vista,  CA  92081
Applicant Contact Kevin Jamil
Correspondent
Biofilm, Inc.
3225 Executive Ridge
Vista,  CA  92081
Correspondent Contact Kevin Jamil
Regulation Number884.5300
Classification Product Code
NUC  
Date Received04/07/2022
Decision Date 07/01/2022
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
Predetermined Change
Control Plan Authorized		 No
-
-