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510(k) K140127

FERROFIBRE STAINLESS STEEL SUTURE WITH CRIMP by Pontis Orthopaedics, LLC — Product Code GAQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 28, 2014
Date Received
January 16, 2014
Clearance Type
Special
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

Other clearances by Pontis Orthopaedics, LLC

  • K133579 — MULTIFILAMENT STAINLESS STEEL SUTURES WITH CRIMPS (June 26, 2014)

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