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510(k) K023594

TENO FIX by Ortheon Medical, LLC — Product Code GAQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 15, 2003
Date Received
October 25, 2002
Clearance Type
Traditional
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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