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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 K990637
Device Name SYNTHES LOCKING RECONSTRUCTION PLATE (LRP) WITH CONDYLAR HEAD
Applicant
Synthes (Usa)
1690 Russell Rd.
Paoli,  PA  19301
Applicant Contact ANGELA SILVESTRI
Correspondent
Synthes (Usa)
1690 Russell Rd.
Paoli,  PA  19301
Correspondent Contact ANGELA SILVESTRI
Regulation Number872.4770
Classification Product Code
NEI  
Date Received02/26/1999
Decision Date 10/22/1999
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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