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 K994095
Device Name LATEX CONDOM
Applicant
THAI NIPPON RUBBER INDUSTRY CO., LTD.
1219 LITTLE CREEK RD.
DURHAM,  NC  27713
Applicant Contact ELI J CARTER
Correspondent
THAI NIPPON RUBBER INDUSTRY CO., LTD.
1219 LITTLE CREEK RD.
DURHAM,  NC  27713
Correspondent Contact ELI J CARTER
Regulation Number884.5300
Classification Product Code
HIS  
Date Received12/03/1999
Decision Date 01/18/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
-
-