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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 K855030
Device Name CHAMPY BONE PLATES & BONE SCREWS
Applicant
Advanced Biosearch Assn.
1700 Rockville Pike
Suite 320
Rockville,  MD  20852
Applicant Contact JOEL S FADEN
Correspondent
Advanced Biosearch Assn.
1700 Rockville Pike
Suite 320
Rockville,  MD  20852
Correspondent Contact JOEL S FADEN
Regulation Number872.4760
Classification Product Code
JEY  
Date Received12/16/1985
Decision Date 01/30/1986
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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