Cleared Traditional

FASTSEAL CHEST WOUND DRESSING

K990079 · Greenfield Medical Technologies, Inc. · General & Plastic Surgery
Dec 1999
Decision
346d
Days
Risk

About This 510(k) Submission

K990079 is an FDA 510(k) clearance for the FASTSEAL CHEST WOUND DRESSING, a Dressing, Wound And Burn, Occlusive, submitted by Greenfield Medical Technologies, Inc. (Northborough, US). The FDA issued a Cleared decision on December 23, 1999, 346 days after receiving the submission on January 11, 1999. This device falls under the General & Plastic Surgery review panel.

Submission Details

510(k) Number K990079 FDA.gov
FDA Decision Cleared SESE
Date Received January 11, 1999
Decision Date December 23, 1999
Days to Decision 346 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement

Device Classification

Product Code MGP — Dressing, Wound And Burn, Occlusive
Device Class

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