MAYFIELD DISPOSABLE AND REUSABLE TITANIUM SKULL PINS


Device Classification Name

holder, head, neurosurgical (skull clamp)

510(k) Number K072208
Device Name MAYFIELD DISPOSABLE AND REUSABLE TITANIUM SKULL PINS
Applicant
INTEGRA LIFESCIENCES CORPORATION
311 enterprise dr.
plainsboro, 
NJ 
08536

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

Correspodent Contact helder a sousa
Regulation Number 882.4460
Classification Product Code
HBL  
Date Received 08/08/2007
Decision Date 09/07/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No