ADVANTAGE DRIVE SYSTEM


information about

Device Classification Name

motor, drill, electric

510(k) Number K002523
Device Name ADVANTAGE DRIVE SYSTEM
Original Applicant
LINVATEC CORP.
11311 concept blvd.
largo, 
FL 
33773 -4908

Original Contact laura d seneff
Regulation Number 882.4360
Classification Product Code
HBC  
Subsequent Product Code
GEY  
Date Received 08/15/2000
Decision Date 10/06/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

General & Plastic Surgery

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls