Cleared Traditional

J TONGS

K930021 · Jerome Medical · Neurology
Dec 1995
Decision
1065d
Days
Class 2
Risk

About This 510(k) Submission

K930021 is an FDA 510(k) clearance for the J TONGS, a Tong, Skull For Traction (Class II — Special Controls, product code HAX), submitted by Jerome Medical (Mt Laurel, US). The FDA issued a Cleared decision on December 6, 1995, 1065 days after receiving the submission on January 5, 1993. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5960.

Submission Details

510(k) Number K930021 FDA.gov
FDA Decision Cleared SESE
Date Received January 05, 1993
Decision Date December 06, 1995
Days to Decision 1065 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement

Device Classification

Product Code HAX — Tong, Skull For Traction
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.5960

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