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 Retractor, Self-Retaining, For Neurosurgery
510(k) Number K071771
Device Name INSTRUMED RETRACTORS
Applicant
Instrumed International, Inc.
626 Cooper Court
Schaumburg,  IL  60173
Applicant Contact MICHAEL MASSONG
Correspondent
Instrumed International, Inc.
626 Cooper Court
Schaumburg,  IL  60173
Correspondent Contact MICHAEL MASSONG
Regulation Number882.4800
Classification Product Code
GZT  
Date Received06/29/2007
Decision Date 08/02/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-