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510(k) K930015

STERNAL BAND by Stony Brook Surgical Innovations, Inc. — Product Code JDQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 19, 1993
Date Received
January 4, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cerclage, Fixation
Device Class
Class II
Regulation Number
888.3010
Review Panel
OR
Submission Type

Other clearances by Stony Brook Surgical Innovations, Inc.

  • K013059 — STONY BROOK SURGICAL INNOVAIONS STERNA-WIRE (STERNAL SUTURES) (October 22, 2001)

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