EMAX 2 PLUS SYSTEM, MODEL EMAX 2 PLUS MOTOR, EMAX 2 CONSOLE>FIRMWARE UPGRADE, EMAX 2 FP FOOT PEDAL


Device Classification Name

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

510(k) Number K080802
Device Name EMAX 2 PLUS SYSTEM, MODEL EMAX 2 PLUS MOTOR, EMAX 2 CONSOLE>FIRMWARE UPGRADE, EMAX 2 FP FOOT PEDAL
Applicant
THE ANSPACH EFFORT, INC.
4500 riverside dr.
palm beach gardens, 
FL 
33410

Applicant Contact jim banic
Correspondent
THE ANSPACH EFFORT, INC.
4500 riverside dr.
palm beach gardens, 
FL 
33410

Correspodent Contact jim banic
Regulation Number 882.4310
Classification Product Code
HBE  
Subsequent Product Codes
GEY   HBF  
Date Received 03/21/2008
Decision Date 04/30/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

General & Plastic Surgery

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls