STERILE RADIOLUCENT SKULL PINS


Device Classification Name

holder, head, neurosurgical (skull clamp)

510(k) Number K122225
Device Name STERILE RADIOLUCENT SKULL PINS
Applicant
BRAINLAB AG
kapellenstrasse 12
feldkirchen, 

DE

85622

Applicant Contact alexander schwiersch
Correspondent
BRAINLAB AG
kapellenstrasse 12
feldkirchen, 

DE

85622

Correspodent Contact alexander schwiersch
Regulation Number 882.4460
Classification Product Code
HBL  
Date Received 07/25/2012
Decision Date 04/26/2013
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No