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 K060145
Device Name FDS INTIMATE AND INTIMATE WARMING LUBRICANT
Applicant
ALBERTO-CULVER USA, INC.
2525 WEST ARMITAGE AVE.
MELROSE PARK,  IL  60148
Applicant Contact RICK MAIN
Correspondent
ALBERTO-CULVER USA, INC.
2525 WEST ARMITAGE AVE.
MELROSE PARK,  IL  60148
Correspondent Contact RICK MAIN
Regulation Number884.5300
Classification Product Code
NUC  
Date Received01/19/2006
Decision Date 04/14/2006
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 Yes
-
-