Cleared Traditional

K812342 - ZEE EXTRICATION DEVICE
(FDA 510(k) Clearance)

K812342 · Zee Medical Products Co., Inc. · Physical Medicine device

Sep 1981

Decision

34d

Days

Class 1

Risk

K812342 is an FDA 510(k) clearance for the ZEE EXTRICATION DEVICE. This device is classified as a Orthosis, Cervical-thoracic, Rigid (Class I - General Controls, product code IQF).

Submitted by Zee Medical Products Co., Inc. (Mchenry, US). The FDA issued a Cleared decision on September 21, 1981, 34 days after receiving the submission on August 18, 1981.

This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3490.

Submission Details

510(k) Number	K812342 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 18, 1981
Decision Date	September 21, 1981
Days to Decision	34 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	—