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, synthetic
510(k) Number K100767
Device Name TROJAN SUPRA LUBRICATED POLYURETHANE MALE CONDOM
Applicant
CHURCH & DWIGHT CO., INC.
469 NORTH HARRISON STREET
PRINCETON,  NJ  08543
Applicant Contact JOSEPH CICCONE
Correspondent
CHURCH & DWIGHT CO., INC.
469 NORTH HARRISON STREET
PRINCETON,  NJ  08543
Correspondent Contact JOSEPH CICCONE
Regulation Number884.5300
Classification Product Code
MOL  
Date Received03/18/2010
Decision Date 04/05/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Clinical Trials NCT01311726
Reviewed by Third Party No
Combination Product No
-
-