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 K120555
Device Name LATEX MALE CONDOM (SMOOTH SURFACE) LATEX MALE CONDOM (TEXTURED SURFACE)
Applicant
MEDICAL-LATEX (DUA) SDN. BHD
PLO 8 SENAI INDUSTRIAL
ESTATE
SENAI,  MY 81400
Applicant Contact UMA DEVI
Correspondent
MEDICAL-LATEX (DUA) SDN. BHD
PLO 8 SENAI INDUSTRIAL
ESTATE
SENAI,  MY 81400
Correspondent Contact UMA DEVI
Regulation Number884.5300
Classification Product Code
HIS  
Date Received02/23/2012
Decision Date 11/02/2012
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
-
-