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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 K002426
Device Name THE BIOPLATE REGID FIXATION BONE PLATING SYSTEM FOR CRANOMAXILLOFACIAL SURGERY
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 Number872.4760
Classification Product Code
JEY  
Date Received08/08/2000
Decision Date 01/26/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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