Cleared Traditional

CERVICAL BRACE

K822780 · Jerome Medical · Orthopedic
Oct 1982
Decision
22d
Days
Class 2
Risk

About This 510(k) Submission

K822780 is an FDA 510(k) clearance for the CERVICAL BRACE, a Component, Traction, Invasive (Class II — Special Controls, product code JEC), submitted by Jerome Medical (Mchenry, US). The FDA issued a Cleared decision on October 6, 1982, 22 days after receiving the submission on September 14, 1982. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K822780 FDA.gov
FDA Decision Cleared SESE
Date Received September 14, 1982
Decision Date October 06, 1982
Days to Decision 22 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary —

Device Classification

Product Code JEC — Component, Traction, Invasive
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3040

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