CODMAN CRANIOTOMY KIT, MODELS 26-1229, 26-1230, 26-1231


Device Classification Name

drills, burrs, trephines & accessories (compound, powered)

510(k) Number K073336
Device Name CODMAN CRANIOTOMY KIT, MODELS 26-1229, 26-1230, 26-1231
Applicant
Codman & Shurtleff, Inc.
325 paramount dr.
raynham, 
MA 
02767 -0350

Applicant Contact emily e valerio
Correspondent
Codman & Shurtleff, Inc.
325 paramount dr.
raynham, 
MA 
02767 -0350

Correspodent Contact emily e valerio
Regulation Number 882.4305
Classification Product Code
HBF  
Date Received 11/28/2007
Decision Date 01/04/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

Type Special
Reviewed by Third Party No

Combination Product

No