J TONGS— 510(k) K930021

Substantially Equivalent

Jerome Medical

FDA 510(k) clearance K930021 for J TONGS, Substantially Equivalent on 1995-12-06. Applicant: Jerome Medical. Device class: 2.

Clearance details

Applicant: Jerome Medical
Product code: Code HAX
Device class: Class 2
Regulation: 21 CFR 882.5960
Advisory panel: Neurology
Date received: 1993-01-05
Decision date: 1995-12-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mt Laurel, 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
K023959 — JEROME GLASS RING2003-02-21
K003662 — SPINE WORKS COLLAR2001-07-09

More clearances from Jerome Medical

K930153 — SYSTEM III HALO RING1993-08-06
K882877 — JMS CERVICAL TRACTION DEVICE/HALO DEVICE1988-09-30
K870053 — TORQUEDRIVER WRENCH1987-03-11
K864969 — JMS HALO APPLICATION TRAY1987-02-18
K844490 — TRACTION ACCESSORIES1985-02-21

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