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510(k) K081428

MODIFICATION TO DOUBLEPLAY SUTURE ANCHOR by Biocomposites, Ltd. — Product Code HWC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 20, 2008
Date Received
May 21, 2008
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Screw, Fixation, Bone
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type

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