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510(k) K934468

SLIP-ON FIXATION SPLINT (SFS) by Gatewood Splints — Product Code EHO

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: August 5, 1994
Date Received: September 10, 1993
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Bar, Preformed
Device Class: Class I
Regulation Number: 872.3165
Review Panel: DE
Submission Type