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 K141059
Device Name NATURAL RUBBER LATEX MALE CONDOMS
Applicant
Karex Industries Sdn. Bhd.
Ptd. 7906/7907, Taman Pontian
Jaya, Bt. 34, Jalan Johor
Pontian Kecil, Jalan Johor,  MY 82000
Applicant Contact MARY GOH
Correspondent
Karex Industries Sdn. Bhd.
Ptd. 7906/7907, Taman Pontian
Jaya, Bt. 34, Jalan Johor
Pontian Kecil, Jalan Johor,  MY 82000
Correspondent Contact MARY GOH
Regulation Number884.5300
Classification Product Code
HIS  
Date Received04/24/2014
Decision Date 08/01/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-