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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 K070901
Device Name MODIFIED PLATE DESIGN FOR BIOPLATE ZIP CRANIOTOMY FIXATION SYSTEM
Applicant
BIOPLATE, INC.
3643 LENAWEE AVE.
LOS ANGELES,  CA  90016 -4310
Applicant Contact JESUS T FARINAS
Correspondent
BIOPLATE, INC.
3643 LENAWEE AVE.
LOS ANGELES,  CA  90016 -4310
Correspondent Contact JESUS T FARINAS
Regulation Number882.5330
Classification Product Code
GXN  
Date Received04/02/2007
Decision Date 06/15/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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