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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Condyle, Mandibular, Temporary
510(k) Number K002790
Device Name ADD-ON CONDYLE
Applicant
Walter Lorenz Surgical, Inc.
11520 Tradeport Dr.
Jacksonville,  FL  32218
Applicant Contact TREVOR BYRD
Correspondent
Walter Lorenz Surgical, Inc.
11520 Tradeport Dr.
Jacksonville,  FL  32218
Correspondent Contact TREVOR BYRD
Regulation Number872.4770
Classification Product Code
NEI  
Date Received09/07/2000
Decision Date 08/06/2001
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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