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510(k) K061089

MODULAR THUMB IMPLANT, MODELS 17600, 17601, 17602, 17603, 17596, 17597, 17598, 17599 by Biopro, Inc. — Product Code KYI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 20, 2006
Date Received
April 18, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Wrist, Carpal Trapezium
Device Class
Class II
Regulation Number
888.3770
Review Panel
OR
Submission Type

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