Cleared Traditional

K033587 - SILVERSEAL
(FDA 510(k) Clearance)

K033587 · Noble Fiber Technologies · General & Plastic Surgery
Aug 2004
Decision
266d
Days
Risk

K033587 is an FDA 510(k) clearance for the SILVERSEAL, a Dressing, Wound, Drug, submitted by Noble Fiber Technologies (Clarks Summit, US). The FDA issued a Cleared decision on August 5, 2004, 266 days after receiving the submission on November 13, 2003. This device falls under the General & Plastic Surgery review panel.

Submission Details

510(k) Number K033587 FDA.gov
FDA Decision Cleared SESE
Date Received November 13, 2003
Decision Date August 05, 2004
Days to Decision 266 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code FRO — Dressing, Wound, Drug
Device Class

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