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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 K082757
Device Name MODIFIED STERILE PLATE & SCREW KIT CONFIGURATIONS FOR USE WITH BIOPLATE TITANIUM FIXATION SYSTEM
Applicant
Bioplate, Inc.
3643 Lenawee Ave.
Los Angeles,  CA  90016
Applicant Contact JESUS T FARINAS
Correspondent
Bioplate, Inc.
3643 Lenawee Ave.
Los Angeles,  CA  90016
Correspondent Contact JESUS T FARINAS
Regulation Number872.4760
Classification Product Code
JEY  
Date Received09/19/2008
Decision Date 10/01/2008
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
Recalls CDRH Recalls
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