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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 K953273
Device Name BIOPLATE RIGID FIXATION BONE PLATING SYSTEM
Applicant
Biomedics
536 Rimpau Blvd.
Los Angeles,  CA  90020
Applicant Contact CAROL E JONES
Correspondent
Biomedics
536 Rimpau Blvd.
Los Angeles,  CA  90020
Correspondent Contact CAROL E JONES
Regulation Number872.4760
Classification Product Code
JEY  
Date Received07/13/1995
Decision Date 09/29/1995
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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