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, Implantable
510(k) Number K132472
Device Name JUSTRIGHT 5MM STAPLER, JUSTRIGHT 5MM RELOAD
Applicant
Justright Surgical, LLC
128 Blye Hill Landing
Newbury,  NH  03255
Applicant Contact MICHELE LUCEY
Correspondent
Justright Surgical, LLC
128 Blye Hill Landing
Newbury,  NH  03255
Correspondent Contact MICHELE LUCEY
Regulation Number878.4750
Classification Product Code
GDW  
Subsequent Product Code
GAG  
Date Received08/07/2013
Decision Date 02/11/2014
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
Recalls CDRH Recalls
-
-