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 K012664
Device Name ULTRA THICK MALE LATEX CONDOM WITH SILICONE LUBRICANT
Applicant
Innolatex Sdn. Bhd
No 16, Jalan Bulan U5/5
Bandar Pinggiran Subang,
Shah Alam,Selangor Darul Ehsan,  MY
Applicant Contact CHANG AH-KAU
Correspondent
Innolatex Sdn. Bhd
No 16, Jalan Bulan U5/5
Bandar Pinggiran Subang,
Shah Alam,Selangor Darul Ehsan,  MY
Correspondent Contact CHANG AH-KAU
Regulation Number884.5300
Classification Product Code
HIS  
Date Received08/13/2001
Decision Date 11/09/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-