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 K002172
Device Name POLY-TAPES (VARIOUS SIZES AND WOVEN CONSTRUCTION VARIANTS)
Applicant
XIROS PLC
28-30 BLENHEIM TERRACE
LEEDS,  GB LS2 9HD
Applicant Contact JIM ROWLAND
Correspondent
XIROS PLC
28-30 BLENHEIM TERRACE
LEEDS,  GB LS2 9HD
Correspondent Contact JIM ROWLAND
Regulation Number878.5000
Classification Product Code
GAT  
Date Received07/19/2000
Decision Date 08/28/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-