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 device, neurovascular embolization
510(k) Number K951314
Device Name TRUEFILL PVA PARTICLES
Applicant
CORDIS NEUROVASCULAR, INC.
14740 N.W. 60TH AVE.
MIAMI LAKES,  FL  33014
Applicant Contact MARLENE W VALENTI
Correspondent
CORDIS NEUROVASCULAR, INC.
14740 N.W. 60TH AVE.
MIAMI LAKES,  FL  33014
Correspondent Contact MARLENE W VALENTI
Regulation Number882.5950
Classification Product Code
HCG  
Date Received03/23/1995
Decision Date 08/08/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-