Cleared Traditional

K833437 - ORTHOPEDIC STOCKINETTE
(FDA 510(k) Clearance)

Nov 1983
Decision
29d
Days
Class 1
Risk

K833437 is an FDA 510(k) clearance for the ORTHOPEDIC STOCKINETTE. This device is classified as a Stocking, Elastic (Class I - General Controls, product code ILG).

Submitted by Northern Medical Surgical, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 3, 1983, 29 days after receiving the submission on October 5, 1983.

This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3475.

Submission Details

510(k) Number K833437 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 05, 1983
Decision Date November 03, 1983
Days to Decision 29 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