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 K020033
Device Name MAXISTAT PVA FOAM EMBOLIZATION PARTICLES
Applicant
SURGICA CORP.
5090 ROBERT J. MATHEWS PKWY.
#4
EL DORADO HILLS,  CA  95762
Applicant Contact LOU MATSON
Correspondent
SURGICA CORP.
5090 ROBERT J. MATHEWS PKWY.
#4
EL DORADO HILLS,  CA  95762
Correspondent Contact LOU MATSON
Regulation Number882.5950
Classification Product Code
HCG  
Date Received01/04/2002
Decision Date 05/31/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-