Cleared Traditional

SURGITEK(R) EXTERNAL FILL PORT

K894495 · Surgitek · General & Plastic Surgery
Jan 1990
Decision
182d
Days
—
Risk

About This 510(k) Submission

K894495 is an FDA 510(k) clearance for the SURGITEK(R) EXTERNAL FILL PORT, a Tissue Expander And Accessories, submitted by Surgitek (Racine, US). The FDA issued a Cleared decision on January 17, 1990, 182 days after receiving the submission on July 19, 1989. This device falls under the General & Plastic Surgery review panel.

Submission Details

510(k) Number K894495 FDA.gov
FDA Decision Cleared SESE
Date Received July 19, 1989
Decision Date January 17, 1990
Days to Decision 182 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary —

Device Classification

Product Code LCJ — Tissue Expander And Accessories
Device Class —

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