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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 K972463
Device Name THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY
Applicant
BIOMEDICS
536 SOUTH RIMPAU BLVD.
LOS ANGELES,  CA  90020
Applicant Contact CAROL E JONES
Correspondent
BIOMEDICS
536 SOUTH RIMPAU BLVD.
LOS ANGELES,  CA  90020
Correspondent Contact CAROL E JONES
Regulation Number872.4760
Classification Product Code
JEY  
Date Received07/01/1997
Decision Date 09/25/1997
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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