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 Staple, Fixation, Bone
510(k) Number K081098
Device Name ENDOBUTTON CONTINUOUS LOOP (CL)
Applicant
Smith & Nephew Inc., Endoscopy Division
150 Minuteman Rd.
Andover,  MA  01810
Applicant Contact CHRISTINA FLORES
Correspondent
Smith & Nephew Inc., Endoscopy Division
150 Minuteman Rd.
Andover,  MA  01810
Correspondent Contact CHRISTINA FLORES
Regulation Number888.3030
Classification Product Code
JDR  
Subsequent Product Codes
HWC   MBI  
Date Received04/17/2008
Decision Date 07/16/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-