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 Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
510(k) Number K912107
Device Name GORE-TEX EXPANDED POLY. CARD. PATCH 0.6 AND 0.4MM
Applicant
W. L. Gore & Associates, Inc.
3450 W. Kiltie Ln.
P.O. Box 500
Flagstaff,  AZ  86002
Applicant Contact BRIAN KUNST
Correspondent
W. L. Gore & Associates, Inc.
3450 W. Kiltie Ln.
P.O. Box 500
Flagstaff,  AZ  86002
Correspondent Contact BRIAN KUNST
Regulation Number870.3470
Classification Product Code
DXZ  
Date Received05/13/1991
Decision Date 10/11/1991
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
-
-