Cleared Traditional

STERILE ORTHOPEDIC STOCKINETTE

K780547 · Alba-Waldensian, Inc. · Physical Medicine
Apr 1978
Decision
5d
Days
Class 1
Risk

About This 510(k) Submission

K780547 is an FDA 510(k) clearance for the STERILE ORTHOPEDIC STOCKINETTE, a Stocking, Elastic (Class I — General Controls, product code ILG), submitted by Alba-Waldensian, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 10, 1978, 5 days after receiving the submission on April 5, 1978. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.3475.

Submission Details

510(k) Number K780547 FDA.gov
FDA Decision Cleared SESE
Date Received April 05, 1978
Decision Date April 10, 1978
Days to Decision 5 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary —

Device Classification

Product Code ILG — Stocking, Elastic
Device Class Class I — General Controls
CFR Regulation 21 CFR 890.3475