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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 K031028
Device Name THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY
Applicant
Bioplate, Inc.
3643 Lenawee Ave.
Los Angeles,  CA  90016
Applicant Contact CAROL E JONES
Correspondent
Bioplate, Inc.
3643 Lenawee Ave.
Los Angeles,  CA  90016
Correspondent Contact CAROL E JONES
Regulation Number872.4760
Classification Product Code
JEY  
Date Received04/01/2003
Decision Date 04/28/2003
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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