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 mesh, surgical
510(k) Number K103787
FOIA Releasable 510(k) K103787
Device Name MEDEOR MATRIX
Applicant
KENSEY NASH CORP.
735 PENNSYLVANIA DRIVE
EXTON,  PA  19341
Applicant Contact Lori Burns
Correspondent
KENSEY NASH CORP.
735 PENNSYLVANIA DRIVE
EXTON,  PA  19341
Correspondent Contact Lori Burns
Regulation Number878.3300
Classification Product Code
FTM  
Subsequent Product Codes
OWY   OXB   OXE   OXH  
Date Received12/27/2010
Decision Date 02/07/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-