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 K090272
Device Name SPETZLER SCALP RETRACTOR CLAMPS (VARIOUS STYLES AND SIZES)
Applicant
CARDINAL HEALTH, INC.
1430 WAUKEGAN ROAD- MPKB-2B
MCGAW PARK,  IL  60085
Applicant Contact GINA RAJTEROWSKI
Correspondent
CARDINAL HEALTH, INC.
1430 WAUKEGAN ROAD- MPKB-2B
MCGAW PARK,  IL  60085
Correspondent Contact GINA RAJTEROWSKI
Regulation Number882.4800
Classification Product Code
GZT  
Date Received02/04/2009
Decision Date 03/18/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-