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, Surgical, Absorbable, Polydioxanone
510(k) Number K030212
Device Name MONODEK SYNTHETIC ABSORBABLE SURGICAL SUTURE
Applicant
Genzyme Biosurgery
600 Airport Rd.
Fall River,  MA  02720
Applicant Contact STEVE PAGE
Correspondent
Genzyme Biosurgery
600 Airport Rd.
Fall River,  MA  02720
Correspondent Contact STEVE PAGE
Regulation Number878.4840
Classification Product Code
NEW  
Date Received01/21/2003
Decision Date 03/27/2003
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-