JEROME GLASS RING— 510(k) K023959

Substantially Equivalent

The Jerome Group, Inc.

FDA 510(k) clearance K023959 for JEROME GLASS RING, Substantially Equivalent on 2003-02-21. Applicant: The Jerome Group, Inc.. Device class: 2.

Clearance details

Applicant: The Jerome Group, Inc.
Product code: Code HAX
Device class: Class 2
Regulation: 21 CFR 882.5960
Advisory panel: Neurology
Date received: 2002-11-27
Decision date: 2003-02-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Moorestown, NJ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HAX

K090733 — PMT HALO SYSTEM2009-07-28
K071173 — RESOLVE TONGS, SMALL/MEDIUM, RESOLVE TONGS, MEDIUM/LARGE, MODEL JT-200D, JT-100D2007-05-25
K051918 — RESOLVE OPEN BACK HALO RINGS2005-08-17
K003662 — SPINE WORKS COLLAR2001-07-09
K980689 — FRIDDLE HALO SYSTEM, FRIDDLE MRI HALO SYSTEM1999-02-18

More clearances from The Jerome Group, Inc.

K040363 — CERAMIC TIPPED SKULL PIN2004-04-12

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