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 K080833
Device Name LOVE GUARD MALE LATEX CONDOM
Applicant
TIANJIN HUMAN-CARE LATEX CORPORATION
56 DANVILLE DRIVE
WEST WINDSOR,  NJ  08550
Applicant Contact SIMON LI
Correspondent
TIANJIN HUMAN-CARE LATEX CORPORATION
56 DANVILLE DRIVE
WEST WINDSOR,  NJ  08550
Correspondent Contact SIMON LI
Regulation Number884.5300
Classification Product Code
HIS  
Date Received03/25/2008
Decision Date 08/07/2008
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
-
-