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510(k) K041117

PANALOK RC QUICKANCHOR PLUS, MODEL 212130, 212730; DUAL SUTURE PANALOK RC QUICKANCHOR PLLUS, MODELS 212132, 212732 by Depuy Mitek — Product Code JDR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 28, 2004
Date Received
April 29, 2004
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Staple, Fixation, Bone
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

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