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
510(k) Number K041837
Device Name INNOLATEX MALE LATEX CONDOMS COLORED AND SCENTED
Applicant
Innolatex Sdn. Bhd
1219 Little Creek Rd.
Durham,  NC  27713
Applicant Contact ELI J CARTER
Correspondent
Innolatex Sdn. Bhd
1219 Little Creek Rd.
Durham,  NC  27713
Correspondent Contact ELI J CARTER
Regulation Number884.5300
Classification Product Code
HIS  
Date Received07/07/2004
Decision Date 09/24/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-