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 prosthesis, vascular graft, of 6mm and greater diameter
510(k) Number K983064
Device Name IMPRA HIGH POROSITY GRAFT
Applicant
IMPRA, INC.
1625 WEST 3RD ST.
P.O. BOX 1740
TEMPE,  AZ  85281
Applicant Contact KRISTI M KISTNER
Correspondent
IMPRA, INC.
1625 WEST 3RD ST.
P.O. BOX 1740
TEMPE,  AZ  85281
Correspondent Contact KRISTI M KISTNER
Regulation Number870.3450
Classification Product Code
DSY  
Date Received09/02/1998
Decision Date 11/19/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-