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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 K060492
Device Name AESCULAP CRANIOFACIAL PLATE AND SCREW
Applicant
Aesculap, Inc.
3773 Corporate Pkwy.
Center Valley,  PA  18034
Applicant Contact MATTHEW M HULL
Correspondent
Aesculap, Inc.
3773 Corporate Pkwy.
Center Valley,  PA  18034
Correspondent Contact MATTHEW M HULL
Regulation Number872.4760
Classification Product Code
JEY  
Date Received02/24/2006
Decision Date 04/07/2006
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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