Cleared Traditional

K050649 - SILVERSEAL CONTACTING WOUND DRESSING WITH X-STATIC
(FDA 510(k) Clearance)

K050649 · Noble Fiber Technologies, Inc. · General & Plastic Surgery

Jun 2005

Decision

91d

Days

—

Risk

K050649 is an FDA 510(k) clearance for the SILVERSEAL CONTACTING WOUND DRESSING WITH X-STATIC. This device is classified as a Dressing, Wound, Drug.

Submitted by Noble Fiber Technologies, Inc. (Clarks Summit, US). The FDA issued a Cleared decision on June 13, 2005, 91 days after receiving the submission on March 14, 2005.

This device falls under the General & Plastic Surgery FDA review panel.

Submission Details

510(k) Number	K050649 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 14, 2005
Decision Date	June 13, 2005
Days to Decision	91 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF