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U.S. Department of Health and Human Services

510(k) Premarket Notification
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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
Correspondent Contact DIANE RUTHERFORD
Regulation Number882.5330
Classification Product Code
GXN  
Date Received03/11/2011
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
Predetermined Change
Control Plan Authorized		 No
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