• 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) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name suture, surgical, absorbable, polydioxanone
510(k) Number K113004
Device Name PDS(TM) BARBED SUTURES
Original Applicant
ETHICON, INC.
route 22 west
p.o. box 151
somerville,  NJ  08876 0151
Original Contact peter cecchini
Regulation Number878.4840
Classification Product Code
NEW  
Date Received10/07/2011
Decision Date 12/20/2011
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
-
-