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 Electrode, Needle
510(k) Number K100912
Device Name DISPOSABLE NERVE STIMULATING PROBE, BIPOLAR CONCENTRIC, DISPOSABLE NERVE STIMULATOR PROBE, BIPOLAR SIDE BY SIDE
Applicant
KIRWAN SURGICAL PRODUCTS, INC.
180 ENTERPRISE DR.
MARSHFIELD,  MA  02050
Applicant Contact KEVIN P PRARIO
Correspondent
KIRWAN SURGICAL PRODUCTS, INC.
180 ENTERPRISE DR.
MARSHFIELD,  MA  02050
Correspondent Contact KEVIN P PRARIO
Regulation Number882.1350
Classification Product Code
GXZ  
Date Received04/01/2010
Decision Date 08/19/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-