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 K882314
Device Name CORONARY VEIN GRAFT MARKER
Applicant
Med-Edge, Inc.
1843 Pinehurst Dr.
Clemmons,  NC  27012
Applicant Contact DEBRA OWENBY
Correspondent
Med-Edge, Inc.
1843 Pinehurst Dr.
Clemmons,  NC  27012
Correspondent Contact DEBRA OWENBY
Regulation Number870.3450
Classification Product Code
DSY  
Date Received06/03/1988
Decision Date 08/04/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-