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510(k) K132510

BIOPRO - INFINITY PLATE ANCHOR SYSTEM by Biopro, Inc. — Product Code HTN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 24, 2013
Date Received
August 12, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Washer, Bolt Nut
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

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  • K082705 — BIOPRO BIPOLAR HEAD, MODELS 18130-18152 (December 15, 2008)
  • K081149 — BIOPRO GO-EZ SCREW (August 5, 2008)

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