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 K121241
Device Name MALE LATEX CONDOM
Applicant
NULATEX SDN. BHD.
LOT 1870, 4TH MLE
MENGKIBOL
KLUANG,  MY 86000
Applicant Contact TEO AI SIANG
Correspondent
NULATEX SDN. BHD.
LOT 1870, 4TH MLE
MENGKIBOL
KLUANG,  MY 86000
Correspondent Contact TEO AI SIANG
Regulation Number884.5300
Classification Product Code
HIS  
Date Received04/25/2012
Decision Date 02/14/2013
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
-
-