• 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 | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back To Search Results
Device Classification Name mesh, surgical
510(k) Number K090880
Device Name XYLOS POROUS SURGICAL MESH
Original Applicant
XYLOS CORPORATION
838 town center dr.
langhorne,  PA  19047
Original Contact joyce elkins
Regulation Number878.3300
Classification Product Code
FTM  
Date Received03/31/2009
Decision Date 05/27/2009
Decision substantially equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-