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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 K910038
Device Name LORENZ ULTRA-MICRO TITANIUM OSTEOSYNTHESIS SYSTEM
Applicant
Walter Lorenz Surgical, Inc.
P.O. Box 18009
Jacksonville,  FL  32229
Applicant Contact DEBRA A POWERS
Correspondent
Walter Lorenz Surgical, Inc.
P.O. Box 18009
Jacksonville,  FL  32229
Correspondent Contact DEBRA A POWERS
Regulation Number872.4760
Classification Product Code
JEY  
Date Received01/04/1991
Decision Date 02/20/1991
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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