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, nonabsorbable, synthetic, polyethylene
510(k) Number K021434
Device Name ARTHREX FIBERWIRE IN USP SIZES
Applicant
ARTHREX, INC.
2885 SOUTH HORSESHOE DR.
NAPLES,  FL  34104
Applicant Contact ANN WATERHOUSE
Correspondent
ARTHREX, INC.
2885 SOUTH HORSESHOE DR.
NAPLES,  FL  34104
Correspondent Contact ANN WATERHOUSE
Regulation Number878.5000
Classification Product Code
GAT  
Date Received05/06/2002
Decision Date 11/07/2002
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
-
-