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, Polymeric
510(k) Number K022011
Device Name V.A.C. ABDOMINAL DRESSING
Applicant
KINETIC CONCEPTS, INC.
8023 VANTAGE DR.
P.O. BOX 659508
SAN ANTONIO,  TX  78265 -9508
Applicant Contact JUDITH A HARBOUR
Correspondent
KINETIC CONCEPTS, INC.
8023 VANTAGE DR.
P.O. BOX 659508
SAN ANTONIO,  TX  78265 -9508
Correspondent Contact JUDITH A HARBOUR
Regulation Number878.3300
Classification Product Code
FTL  
Date Received06/19/2002
Decision Date 02/26/2003
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
Recalls CDRH Recalls
-
-