BRACE, TENNIS ELBOW— 510(k) K780053

Name: FDA 510(k) clearance K780053
Creator: U.S. Food and Drug Administration
Published: 1978-01-17

Substantially Equivalent

Bd Becton Dickinson Vacutainer Systems Preanalytic

FDA 510(k) clearance K780053 for BRACE, TENNIS ELBOW, Substantially Equivalent on 1978-01-17. Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic. Device class: 1.

Clearance details

Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic
Product code: Code IQI
Device class: Class 1
Regulation: 21 CFR 890.3475
Advisory panel: Physical Medicine
Date received: 1978-01-09
Decision date: 1978-01-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code IQI

view all

K143458 — Neurosplint2015-08-13
K052771 — SENSOR WALK2006-05-03
K031576 — SPARTAN ORTHOPAEDIC WRIST BRACE, MODEL SCT-12003-07-31
K926391 — ACCUFLEX DYNAMIC ELBOW ORTHOSIS1993-07-22
K910974 — MCCONNELL SHOULDER BRACE1991-03-21

More clearances from Bd Becton Dickinson Vacutainer Systems Preanalytic

view all

K003062 — BACTEC MGIT 960 SIR KITS2001-06-06
K003553 — 0.9% SODIUM CHLORIDE INJECTION, USP BD PRE-FILLED FLUSH SYRINGE2001-03-21
K003461 — BD VACUTAINER PASSIVE SHIELDING BLOOD COLLECTION NEEDLE2001-02-01
K002938 — B-D ULTRA-FINE III PEN NEEDLE; MODEL 31G X 3/162000-11-29
K001364 — BD DIRECTIGEN FLU A+B2000-06-28

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