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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 K030425
Device Name LORENZ RESORBABLE DISTRACTION SYSTEM OR EXPANDER
Applicant
Walter Lorenz Surgical, Inc.
1520 Tradeport Dr.
Jacksonville,  FL  32218
Applicant Contact KIM REED
Correspondent
Walter Lorenz Surgical, Inc.
1520 Tradeport Dr.
Jacksonville,  FL  32218
Correspondent Contact KIM REED
Regulation Number872.4760
Classification Product Code
JEY  
Date Received02/10/2003
Decision Date 05/14/2004
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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