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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Bone
510(k) Number K023810
Device Name MODIFICATION TO BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY
Applicant
Bioplate, Inc.
6911 Melrose Ave.
Los Angeles,  CA  90038
Applicant Contact JUDY SOKUA
Correspondent
Bioplate, Inc.
6911 Melrose Ave.
Los Angeles,  CA  90038
Correspondent Contact JUDY SOKUA
Regulation Number872.4760
Classification Product Code
JEY  
Date Received11/15/2002
Decision Date 12/04/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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