Cleared Traditional

TISSUE EXPANDER

K840464 · Surgitek · General & Plastic Surgery
Mar 1984
Decision
38d
Days
—
Risk

About This 510(k) Submission

K840464 is an FDA 510(k) clearance for the TISSUE EXPANDER, a Tissue Expander And Accessories, submitted by Surgitek (Mchenry, US). The FDA issued a Cleared decision on March 12, 1984, 38 days after receiving the submission on February 3, 1984. This device falls under the General & Plastic Surgery review panel.

Submission Details

510(k) Number K840464 FDA.gov
FDA Decision Cleared SESE
Date Received February 03, 1984
Decision Date March 12, 1984
Days to Decision 38 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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