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 Condom With Nonoxynol-9
510(k) Number K033163
Device Name CAUTION CONDOMS
Applicant
Richard Van Haussen America, Inc.
5777 W. Century Blvd.
#1648
Los Angeles,  CA  90045
Applicant Contact RICHARD QUAISON
Correspondent
Richard Van Haussen America, Inc.
5777 W. Century Blvd.
#1648
Los Angeles,  CA  90045
Correspondent Contact RICHARD QUAISON
Regulation Number884.5310
Classification Product Code
LTZ  
Date Received11/07/2003
Decision Date 04/27/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
-
-