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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screw, Fixation, Intraosseous
510(k) Number K012908
Device Name BIOPLATE RESORBABLE BONE SCREW
Applicant
Bioplate, Inc.
6911 Melrose Ave.
Los Angeles,  CA  90038
Applicant Contact ERIC V HOHENSTEIN
Correspondent
Bioplate, Inc.
6911 Melrose Ave.
Los Angeles,  CA  90038
Correspondent Contact ERIC V HOHENSTEIN
Regulation Number872.4880
Classification Product Code
DZL  
Subsequent Product Code
JEY  
Date Received08/30/2001
Decision Date 11/28/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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