• 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 K081886
Device Name KAREX INDUSTRIES MALE NATURAL RUBBER LATEX CONDOM, NON-SPERMICIDAL, LUBRICATED AND NON LUBRICATED
Applicant
KAREX INDUSTRIES SDN BHD
PTD. 7906/7907, TAMAN PONTIAN
JAYA, BT. 34, JALAN JOHOR
pontian, johor,  MY 82000
Applicant Contact leng kian goh
Correspondent
KAREX INDUSTRIES SDN BHD
PTD. 7906/7907, TAMAN PONTIAN
JAYA, BT. 34, JALAN JOHOR
pontian, johor,  MY 82000
Correspondent Contact leng kian goh
Regulation Number884.5300
Classification Product Code
HIS  
Date Received07/02/2008
Decision Date 02/06/2009
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
-
-