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 Cuff, Nerve
510(k) Number K011168
Device Name NEUROGEN NERVE GUIDE
Applicant
INTEGRA LIFESCIENCES CORP.
105 MORGAN LANE
PLAINSBORO,  NJ  08536
Applicant Contact JUDITH E O'GRADY
Correspondent
INTEGRA LIFESCIENCES CORP.
105 MORGAN LANE
PLAINSBORO,  NJ  08536
Correspondent Contact JUDITH E O'GRADY
Regulation Number882.5275
Classification Product Code
JXI  
Date Received04/17/2001
Decision Date 06/22/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-