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 Rongeur, Manual
510(k) Number K161744
Device Name Symmetry Sharp Kerrison Rongeur
Applicant
Symmetry Surgical, Inc.
3034 Owen Dr.
Antioch,  TN  37013
Applicant Contact Lora Tjomstol
Correspondent
Lakeshore Medical Device Consulting, LLC
128 Blye Hill Landing
Newbury,  NH  03255
Correspondent Contact Michele Lucey
Regulation Number882.4840
Classification Product Code
HAE  
Date Received06/24/2016
Decision Date 09/07/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-