Cleared Traditional

QUICK-CAST IMMOBILIZER

K932507 · Landec Corp. · Orthopedic

Feb 1994

Decision

274d

Days

Class 1

Risk

About This 510(k) Submission

K932507 is an FDA 510(k) clearance for the QUICK-CAST IMMOBILIZER, a Component, Cast (Class I — General Controls, product code LGF), submitted by Landec Corp. (Menlo Park, US). The FDA issued a Cleared decision on February 23, 1994, 274 days after receiving the submission on May 25, 1993. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.5940.

Submission Details

510(k) Number	K932507 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 25, 1993
Decision Date	February 23, 1994
Days to Decision	274 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF