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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 K022012
Device Name SYNTHES LOW PROFILE NEURO SYSTEM
Applicant
Synthes (Usa)
P.O. Box 1766
1690 Russell Rd.
Paoli,  PA  19301 -1222
Applicant Contact MATTHEW M HULL
Correspondent
Synthes (Usa)
P.O. Box 1766
1690 Russell Rd.
Paoli,  PA  19301 -1222
Correspondent Contact MATTHEW M HULL
Regulation Number872.4760
Classification Product Code
JEY  
Date Received06/20/2002
Decision Date 11/01/2002
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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