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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cover, Burr Hole
510(k) Number K040080
Device Name AESCULAP ABSORBABLE CRANIOFIX
Applicant
AESCULAP, INC.
3773 Corporate Parkway
Center Valley,  PA  18034
Applicant Contact MATTHEW M HULL
Correspondent
AESCULAP, INC.
3773 Corporate Parkway
Center Valley,  PA  18034
Correspondent Contact MATTHEW M HULL
Regulation Number882.5250
Classification Product Code
GXR  
Date Received01/15/2004
Decision Date 03/31/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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