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, Silk
510(k) Number K162396
Device Name SILK Surgical Suture
Applicant
TELEFLEX MEDICAL, INC
3015 CARRINGTON MILL BLVD
MORRISVILLE,  NC  27560
Applicant Contact NATALIE HICHAK
Correspondent
TELEFLEX MEDICAL, INC
3015 CARRINGTON MILL BLVD
MORRISVILLE,  NC  27560
Correspondent Contact NATALIE HICHAK
Regulation Number878.5030
Classification Product Code
GAP  
Date Received08/26/2016
Decision Date 11/23/2016
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
-
-