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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 K020088
Device Name MODIFICATION OF THE BIOPLATE ZIP CRANIOTOMY FIXATION SYSTEM
Applicant
BIOPLATE, INC.
6911 MELROSE AVE.
LOS ANGELES,  CA  90038
Applicant Contact CAROL E JONES
Correspondent
BIOPLATE, INC.
6911 MELROSE AVE.
LOS ANGELES,  CA  90038
Correspondent Contact CAROL E JONES
Regulation Number882.5330
Classification Product Code
GXN  
Date Received01/10/2002
Decision Date 02/08/2002
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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