• 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 K023128
Device Name NON-SPERMICIDAL LUBRICATED MALE LATEX CONDOM
Applicant
SECURE SCIENTIFIC SDN BHD
LOT 122, KAMPUNG TITI TOK ARIS
SUNGAI SELUANG
lunas, kedah,  MY 09600
Applicant Contact chong ngit-heng
Correspondent
SECURE SCIENTIFIC SDN BHD
LOT 122, KAMPUNG TITI TOK ARIS
SUNGAI SELUANG
lunas, kedah,  MY 09600
Correspondent Contact chong ngit-heng
Regulation Number884.5300
Classification Product Code
HIS  
Date Received09/19/2002
Decision Date 01/22/2003
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
-
-