TRUNCAL ORTHOSIS— 510(k) K821682

Name: FDA 510(k) clearance K821682
Creator: U.S. Food and Drug Administration
Published: 1982-06-24

Substantially Equivalent

Surgical Appliance Industries, Inc.

FDA 510(k) clearance K821682 for TRUNCAL ORTHOSIS, Substantially Equivalent on 1982-06-24. Applicant: Surgical Appliance Industries, Inc.. Device class: 1.

Clearance details

Applicant: Surgical Appliance Industries, Inc.
Product code: Code IQE
Device class: Class 1
Regulation: 21 CFR 890.3490
Advisory panel: Physical Medicine
Date received: 1982-06-08
Decision date: 1982-06-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code IQE

view all

K820051 — OBUS FORME ORTHOPEDIC BRACE, UPRIGHT1982-01-29
K812719 — PROSANA BELT1981-10-06
K810450 — TRUNCAL ORTHOSIS1981-03-04

More clearances from Surgical Appliance Industries, Inc.

view all

K121106 — TRUFORM READY-TO-WEAR COMPRESSION ARM SLEECE TRUFORM READY-TO-WEAR COMPRESSION GAUNTLET2012-04-27
K813416 — EXTERNAL BREAST PROSTHESIS1982-01-18
K812401 — CRUCIFORM ANTERIOR SPINAL HYPEREXTEN. O1981-09-14
K812422 — CUSTOM CONTOUR LUMBOSACRAL ORTHOSIS1981-09-14
K812423 — NEOPRENE KNEE SUPPORT1981-09-14

Data sourced from openFDA. This site is unofficial and independent of the FDA.