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 K020659
FOIA Releasable 510(k) K020659
Device Name DUREX LATEX CONDOM WITH MALE GENITAL DESENSITIZER LUBRICANT
Applicant
SSL AMERICAS, INC.
3585 ENGINEERING DR.; STE 200
P.O. BOX 926090
NORCROSS,  GA  30092 -9214
Applicant Contact JOYCE NING
Correspondent
SSL AMERICAS, INC.
3585 ENGINEERING DR.; STE 200
P.O. BOX 926090
NORCROSS,  GA  30092 -9214
Correspondent Contact JOYCE NING
Regulation Number884.5300
Classification Product Code
HIS  
Date Received03/01/2002
Decision Date 03/29/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-