Cleared Traditional

CASTALERT

K861292 · Walgen Medical Innoventions · Orthopedic
May 1986
Decision
35d
Days
—
Risk

About This 510(k) Submission

K861292 is an FDA 510(k) clearance for the CASTALERT, submitted by Walgen Medical Innoventions (Syracuse, US). The FDA issued a Cleared decision on May 12, 1986, 35 days after receiving the submission on April 7, 1986. This device falls under the Orthopedic review panel.

Submission Details

510(k) Number K861292 FDA.gov
FDA Decision Cleared SESE
Date Received April 07, 1986
Decision Date May 12, 1986
Days to Decision 35 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary —

Device Classification

Product Code —
Device Class —