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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 K030069
Device Name SYNTHES POLY (L-LACTIDE-CO-GLYCOLIDE) RESORBABLE FIXATION SYSTEM
Applicant
Synthes (Usa)
1690 Russell Rd.
Post Office Box 1766
Paoli,  PA  19301
Applicant Contact BONNIE J SMITH
Correspondent
Synthes (Usa)
1690 Russell Rd.
Post Office Box 1766
Paoli,  PA  19301
Correspondent Contact BONNIE J SMITH
Regulation Number872.4760
Classification Product Code
JEY  
Date Received01/08/2003
Decision Date 04/08/2003
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
Recalls CDRH Recalls
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