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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 -2480
Applicant Contact TREVOR BYRD
Correspondent
Walter Lorenz Surgical, Inc.
11520 Tradeport Dr.
Jacksonville,  FL  32218 -2480
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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