Cleared Traditional

K863865 - TENSOTAPE SURGICAL ADHESIVE TAPE (FDA 510(k) Clearance)

Nov 1986
Decision
42d
Days
Risk

K863865 is an FDA 510(k) clearance for the TENSOTAPE SURGICAL ADHESIVE TAPE..

Submitted by Smith & Nephew, Inc. (Massillon, US). The FDA issued a Cleared decision on November 14, 1986, 42 days after receiving the submission on October 3, 1986.

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

Submission Details

510(k) Number K863865 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 1986
Decision Date November 14, 1986
Days to Decision 42 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary

Device Classification

Product Code
Device Class