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510(k) K023372

NON-BIOABSORBABLE STAPLE by Onux Medical, Inc. — Product Code NJU

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: December 27, 2002
Date Received: October 8, 2002
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Suture, Nonabsorbable, Nitinol
Device Class: Class II
Regulation Number: 878.4495
Review Panel: SU
Submission Type

Soft tissue approximation.