HEAD FIATION DEVICE (HFD 100)


Device Classification Name

holder, head, neurosurgical (skull clamp)

510(k) Number K103493
Device Name HEAD FIATION DEVICE (HFD 100)
Applicant
IMRIS, INC.
16809 briardale road
rockville, 
MD 
20855

Applicant Contact thomas m tskeris
Correspondent
IMRIS, INC.
16809 briardale road
rockville, 
MD 
20855

Correspodent Contact thomas m tskeris
Regulation Number 882.4460
Classification Product Code
HBL  
Date Received 11/29/2010
Decision Date 03/11/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No