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 K002571
Device Name MULITPLE MALE LATX CONDOM
Applicant
Pleasure Latex Products Sdn. Bhd.
Lot 1365, 17th Miles, Jalan
Sungai Sembilang
Jeram, Selangor Darul Ehsan,  MY 45800
Applicant Contact KOI-YONG LIM
Correspondent
Pleasure Latex Products Sdn. Bhd.
Lot 1365, 17th Miles, Jalan
Sungai Sembilang
Jeram, Selangor Darul Ehsan,  MY 45800
Correspondent Contact KOI-YONG LIM
Regulation Number884.5300
Classification Product Code
HIS  
Date Received08/18/2000
Decision Date 11/16/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-