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510(k) K982951

IMTEC BIOPIN by Imtec Corp. — Product Code DZL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 21, 1999
Date Received
August 24, 1998
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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  • K024044 — SABER TECH IMPLANTS SYSTEM (February 21, 2003)

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