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 K034039
Device Name SIS PLASTIC SURGERY MATRIX
Applicant
COOK BIOTECH, INC.
3055 KENT AVE.
WEST LAFAYETTE,  IN  47906 -1076
Applicant Contact MARK BLEYER
Correspondent
COOK BIOTECH, INC.
3055 KENT AVE.
WEST LAFAYETTE,  IN  47906 -1076
Correspondent Contact MARK BLEYER
Regulation Number878.3300
Classification Product Code
FTM  
Date Received12/29/2003
Decision Date 02/18/2004
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
-
-