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510(k) K972691

ABC TOTAL ELBOW PROTHESIS by Biomet, Inc. — Product Code JDB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 15, 1997
Date Received
July 17, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Elbow, Semi-Constrained, Cemented
Device Class
Class II
Regulation Number
888.3160
Review Panel
OR
Submission Type

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