Cleared Traditional

INFECTIOUS TISSUE KIT

K864824 · American Scientific Products · General & Plastic Surgery
Dec 1986
Decision
15d
Days
Risk

About This 510(k) Submission

K864824 is an FDA 510(k) clearance for the INFECTIOUS TISSUE KIT, submitted by American Scientific Products (Waukegan, US). The FDA issued a Cleared decision on December 24, 1986, 15 days after receiving the submission on December 9, 1986. This device falls under the General & Plastic Surgery review panel.

Submission Details

510(k) Number K864824 FDA.gov
FDA Decision Cleared SESE
Date Received December 09, 1986
Decision Date December 24, 1986
Days to Decision 15 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary

Device Classification

Product Code
Device Class