MEDCAD ACCUSHAPE (TM) PEEK PATIENT SPECIFIC CRANIAL / CRANIOFACIAL IMPLANT


Device Classification Name

plate, cranioplasty, preformed, non-alterable

510(k) Number K110684
Device Name MEDCAD ACCUSHAPE (TM) PEEK PATIENT SPECIFIC CRANIAL / CRANIOFACIAL IMPLANT
Applicant
VANDUZEN DBA MEDCAD
1201 richardson
suite 280
richardson, 
TX 
75080

Applicant Contact diane rutherford
Correspondent
VANDUZEN DBA MEDCAD
1201 richardson
suite 280
richardson, 
TX 
75080

Correspodent Contact diane rutherford
Regulation Number 882.5330
Classification Product Code
GXN  
Date Received 03/11/2011
Decision Date 06/24/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No