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 K974121
Device Name LUBRICATED BAGGY TACTYLON CONDOM
Applicant
Sensicon Corp.
2595 Commerce Way
Vista,  CA  92083
Applicant Contact JEFF D GRANT
Correspondent
Sensicon Corp.
2595 Commerce Way
Vista,  CA  92083
Correspondent Contact JEFF D GRANT
Regulation Number884.5300
Classification Product Code
MOL  
Date Received10/31/1997
Decision Date 01/29/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-