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510(k) K013059

STONY BROOK SURGICAL INNOVAIONS STERNA-WIRE (STERNAL SUTURES) by Stony Brook Surgical Innovations, Inc. — Product Code GAQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 22, 2001
Date Received
September 11, 2001
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

Other clearances by Stony Brook Surgical Innovations, Inc.

  • K930015 — STERNAL BAND (May 19, 1993)

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