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510(k) K992462

OSTEONICS UNIVERSAL DISTAL CEMENT PLUG by Howmedica Osteonics Corp. — Product Code LZN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 13, 1999
Date Received
July 23, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cement Obturator
Device Class
Class II
Regulation Number
878.3300
Review Panel
OR
Submission Type

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