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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 K854886
Device Name WUERZBURG TITANIUM MINI BONE PLATES & BONE SCREWS
Applicant
Walter Lorenz Surgical, Inc.
Advanced Biosearch Associates
1700 Rockville Pike Suite 320
Rockville,  MD  20852
Applicant Contact JOEL FADEN
Correspondent
Walter Lorenz Surgical, Inc.
Advanced Biosearch Associates
1700 Rockville Pike Suite 320
Rockville,  MD  20852
Correspondent Contact JOEL FADEN
Regulation Number872.4760
Classification Product Code
JEY  
Date Received12/06/1985
Decision Date 01/21/1986
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
Recalls CDRH Recalls
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