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 K081366
Device Name KUMAR T-ANCHORS HERNIA SET
Applicant
Nashville Surgical Instruments
2005 Kumar Lane
Springfield,  TN  37172
Applicant Contact SARBJEET KUMAR
Correspondent
Nashville Surgical Instruments
2005 Kumar Lane
Springfield,  TN  37172
Correspondent Contact SARBJEET KUMAR
Regulation Number878.5020
Classification Product Code
GAR  
Date Received05/15/2008
Decision Date 07/15/2008
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
-
-