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510(k) K040080

AESCULAP ABSORBABLE CRANIOFIX by Aesculap, Inc. — Product Code GXR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 31, 2004
Date Received
January 15, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cover, Burr Hole
Device Class
Class II
Regulation Number
882.5250
Review Panel
NE
Submission Type

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