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510(k) K082010

STRYKER DISPOSABLE CRANIAL PERFORATOR BIT by Stryker Ireland Ltd., Instruments Division — Product Code HBF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 29, 2008
Date Received
July 15, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Drills, Burrs, Trephines & Accessories (Compound, Powered)
Device Class
Class II
Regulation Number
882.4305
Review Panel
NE
Submission Type

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