Cleared Traditional

SURGITEK INTRA-SPAN INTRAOPERATIVE TISSUE EXPANDER

K902349 · Surgitek · General & Plastic Surgery
Sep 1990
Decision
103d
Days
Class 1
Risk

About This 510(k) Submission

K902349 is an FDA 510(k) clearance for the SURGITEK INTRA-SPAN INTRAOPERATIVE TISSUE EXPANDER, a Expander, Surgical, Skin Graft (Class I — General Controls, product code FZW), submitted by Surgitek (Paso Robles, US). The FDA issued a Cleared decision on September 5, 1990, 103 days after receiving the submission on May 25, 1990. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number K902349 FDA.gov
FDA Decision Cleared SESE
Date Received May 25, 1990
Decision Date September 05, 1990
Days to Decision 103 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary —

Device Classification

Product Code FZW — Expander, Surgical, Skin Graft
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4800

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