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 K060097
Device Name GROSSMAN SELF-RETAINING LOW PROFILE BRAIN RETRACTOR, MODEL 04-001-00
Applicant
KLS-MARTIN L.P.
11239 ST. JOHNS INDUSTRIAL
PARKWAY SOUTH
JACKSONVILLE,  FL  32246
Applicant Contact JENNIFER DAMATO
Correspondent
KLS-MARTIN L.P.
11239 ST. JOHNS INDUSTRIAL
PARKWAY SOUTH
JACKSONVILLE,  FL  32246
Correspondent Contact JENNIFER DAMATO
Regulation Number882.4800
Classification Product Code
GZT  
Date Received01/13/2006
Decision Date 02/27/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-