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510(k) K081060

FERROFIBRE STAINLESS STEEL SUTURES, MODEL 610 SERIES SIZES (USP) 5-0 TO #5 by Core Essence Orthopaedics, LLC — Product Code GAQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 24, 2008
Date Received
April 14, 2008
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile
Device Class
Class II
Regulation Number
878.4495
Review Panel
SU
Submission Type

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