HALLU PLATES


Device Classification Name

plate, fixation, bone

510(k) Number K021626
Device Name HALLU PLATES
Original Applicant
NEWDEAL S.A.
9109 copenhaver dr.
potomac, 
MD 
20854

Original Contact norman f estrin
Regulation Number 888.3030
Classification Product Code
HRS  
Date Received 05/17/2002
Decision Date 08/12/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No