NON-INVASIVE PATIENT FIXATION SYSTEM


Device Classification Name

accelerator, linear, medical

510(k) Number K023449
Device Name NON-INVASIVE PATIENT FIXATION SYSTEM
Original Applicant
STRYKER LEIBINGER
4100 east milham ave.
kalamazoo, 
MI 
49001

Original Contact kelli j bitterburg
Regulation Number 892.5050
Classification Product Code
IYE  
Date Received 10/15/2002
Decision Date 01/13/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No