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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Spinal Intervertebral Body
510(k) Number K040017
Device Name ABC CAUDAL AND CRANIAL EXTENSION PLATE (E-PLATE)
Applicant
Aesculap, Inc.
3 773 Corporate Pkwy.
Center Valley,  PA  18034
Applicant Contact JONI L SWOVELAND
Correspondent
Aesculap, Inc.
3 773 Corporate Pkwy.
Center Valley,  PA  18034
Correspondent Contact JONI L SWOVELAND
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received01/06/2004
Decision Date 05/14/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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