Cleared Traditional

JEROME GLASS RING

K023959 · The Jerome Group, Inc. · Neurology

Feb 2003

Decision

86d

Days

Class 2

Risk

About This 510(k) Submission

K023959 is an FDA 510(k) clearance for the JEROME GLASS RING, a Tong, Skull For Traction (Class II — Special Controls, product code HAX), submitted by The Jerome Group, Inc. (Moorestown, US). The FDA issued a Cleared decision on February 21, 2003, 86 days after receiving the submission on November 27, 2002. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5960.

Submission Details

510(k) Number	K023959 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 27, 2002
Decision Date	February 21, 2003
Days to Decision	86 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF