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 K945145
Device Name RIA LATEX CONDOM, NONOXYNOL-9
Applicant
Mbf Personal Care Sdn. Bhd.
Plo 22,Senai Industrial Estate
Phase 1
Senai, Johor,  MY 81400
Applicant Contact P K REDDY
Correspondent
Mbf Personal Care Sdn. Bhd.
Plo 22,Senai Industrial Estate
Phase 1
Senai, Johor,  MY 81400
Correspondent Contact P K REDDY
Regulation Number884.5300
Classification Product Code
HIS  
Date Received10/20/1994
Decision Date 02/21/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-