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 K000748
Device Name TROJAN LATEX CONDOM WITH MALE GENITAL DESENSITIZER LUBRICANT
Applicant
Armkel, LLC
P.O. Box 1001, Half Acre Rd.
Cranbury,  NJ  08512
Applicant Contact STEPHEN C KOLAKOWSKY
Correspondent
Armkel, LLC
P.O. Box 1001, Half Acre Rd.
Cranbury,  NJ  08512
Correspondent Contact STEPHEN C KOLAKOWSKY
Regulation Number884.5300
Classification Product Code
HIS  
Date Received03/08/2000
Decision Date 04/06/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-