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 K864473
Device Name SEMINAL FLUID COLLECTION KIT(TM)
Applicant
APEX TECHNOLOGIES, INC.
9842 HIBERT ST.
SUITE #282
SAN DIEGO,  CA  92131
Applicant Contact ALICE A DEPAUL
Correspondent
APEX TECHNOLOGIES, INC.
9842 HIBERT ST.
SUITE #282
SAN DIEGO,  CA  92131
Correspondent Contact ALICE A DEPAUL
Regulation Number884.5300
Classification Product Code
HIS  
Date Received11/13/1986
Decision Date 12/03/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-