Cleared Traditional

K850375 - MICROSURGERY VISIBILITY BACKGROUND MATERIAL (FDA 510(k) Clearance)

Apr 1985
Decision
67d
Days
Risk

K850375 is an FDA 510(k) clearance for the MICROSURGERY VISIBILITY BACKGROUND MATERIAL..

Submitted by Ethicon, Inc. (Somerville, US). The FDA issued a Cleared decision on April 8, 1985, 67 days after receiving the submission on January 31, 1985.

This device falls under the General & Plastic Surgery FDA review panel.

Submission Details

510(k) Number K850375 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 1985
Decision Date April 08, 1985
Days to Decision 67 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary

Device Classification

Product Code
Device Class