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510(k) K051256

SILVERSEAL ORTHOTIC COMPONENT WITH X-STATIC by Noble Fiber Technologies, Inc. — Product Code ISH

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: July 21, 2005
Date Received: May 16, 2005
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Component, External, Limb, Ankle/Foot
Device Class: Class I
Regulation Number: 890.3420
Review Panel: PM
Submission Type

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K043526 — SILVERSEAL TUBULAR WOUND DRESSING WITH X-STATIC (March 10, 2005)
K033900 — X-STATIC SILVERSEAL HYDROCOLLOID FILM AND ISLAND DRESSING (January 14, 2005)
K033587 — SILVERSEAL (August 5, 2004)
K040019 — SILVERSEAL (July 23, 2004)