• 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, Polymeric
510(k) Number K122436
Device Name COMPOSIX L/P MESH WITH ECHO PS POSITIONING SYSTEM VENTRALIGHT ST MESH WITH ECHO PS POSITIONING SYSTEM
Applicant
C.R. BARD, INC.
100 CROSSINGS BOULEVARD
WARWICK,  RI  02886
Applicant Contact KETI SINO
Correspondent
C.R. BARD, INC.
100 CROSSINGS BOULEVARD
WARWICK,  RI  02886
Correspondent Contact KETI SINO
Regulation Number878.3300
Classification Product Code
FTL  
Subsequent Product Codes
GCJ   OQL  
Date Received08/10/2012
Decision Date 11/02/2012
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
Recalls CDRH Recalls
-
-