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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 K012910
Device Name THE BIOPLATE MANDIBLE FIXATION SYSTEM
Applicant
Bioplate, Inc.
1666 K St. NW
Suite 200
Washington,  DC  20006
Applicant Contact BRUCE F MACKLER
Correspondent
Bioplate, Inc.
1666 K St. NW
Suite 200
Washington,  DC  20006
Correspondent Contact BRUCE F MACKLER
Regulation Number872.4760
Classification Product Code
JEY  
Date Received08/30/2001
Decision Date 11/20/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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