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 suture, absorbable, natural
510(k) Number K042897
Device Name AUTOBAHN TISSUE CLOSURE DEVICE AND DISPOSABLE CARTRIDGE
Applicant
ETHICON ENDO-SURGERY, INC.
4545 CREEK RD.
CINCINNATI,  OH  45242 -2839
Applicant Contact ELIZABETH MILLER
Correspondent
ETHICON ENDO-SURGERY, INC.
4545 CREEK RD.
CINCINNATI,  OH  45242 -2839
Correspondent Contact ELIZABETH MILLER
Regulation Number878.4830
Classification Product Code
GAL  
Subsequent Product Codes
GAM   GAP   GAQ   GDF   NBY  
NJU  
Date Received10/20/2004
Decision Date 11/19/2004
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
-
-