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, Polyamide
510(k) Number K052900
Device Name QUILL NONABSORBABLE NYLON BARBED SUTURE
Applicant
Quill Medical, Inc.
2505 Meridian Pkwy.
Suite 150
Research Triangle Park,  NC  27713
Applicant Contact LOIS V SMART
Correspondent
Quill Medical, Inc.
2505 Meridian Pkwy.
Suite 150
Research Triangle Park,  NC  27713
Correspondent Contact LOIS V SMART
Regulation Number878.5020
Classification Product Code
GAR  
Date Received10/14/2005
Decision Date 11/28/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-