MAYFIELD MR/X-RAY SKULL CLAMP


Device Classification Name

holder, head, neurosurgical (skull clamp)

510(k) Number K081401
Device Name MAYFIELD MR/X-RAY SKULL CLAMP
Applicant
INTEGRA LIFESCIENCES CORP.
311 enterprise dr.
plainsboro, 
NJ 
08536

Applicant Contact helder a sousa
Correspondent
INTEGRA LIFESCIENCES CORP.
311 enterprise dr.
plainsboro, 
NJ 
08536

Correspodent Contact helder a sousa
Regulation Number 882.4460
Classification Product Code
HBL  
Date Received 05/19/2008
Decision Date 10/08/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No