NEWGEN SYSTEM


Device Classification Name

plate, bone

510(k) Number K002619
Device Name NEWGEN SYSTEM
Original Applicant
STRYKER INSTRUMENTS
4100 east milham ave.
kalamazoo, 
MI 
49001 -6197

Original Contact robin l rowe
Regulation Number 872.4760
Classification Product Code
JEY  
Date Received 08/23/2000
Decision Date 11/16/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

Type Traditional
Reviewed by Third Party No

Combination Product

No