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510(k) K974392

LEADFIX BIORESORBABLE MEMBRANCE PIN SYSTEM by Biovision GmbH — Product Code DZL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 30, 1998
Date Received
November 21, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Screw, Fixation, Intraosseous
Device Class
Class II
Regulation Number
872.4880
Review Panel
DE
Submission Type

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