Cleared Traditional

SILVERSEAL TUBULAR WOUND DRESSING WITH X-STATIC

K043526 · Noble Fiber Technologies, Inc. · Orthopedic

Mar 2005

Decision

79d

Days

Class 1

Risk

About This 510(k) Submission

K043526 is an FDA 510(k) clearance for the SILVERSEAL TUBULAR WOUND DRESSING WITH X-STATIC, a Component, Cast (Class I — General Controls, product code LGF), submitted by Noble Fiber Technologies, Inc. (Clarks Summit, US). The FDA issued a Cleared decision on March 10, 2005, 79 days after receiving the submission on December 21, 2004. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.5940.

Submission Details

510(k) Number	K043526 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 21, 2004
Decision Date	March 10, 2005
Days to Decision	79 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF