Cleared Traditional

K781761 - KENDRICK EXTRICATION DEVICE (FDA 510(k) Clearance)

Oct 1978
Decision
11d
Days
Class 1
Risk

K781761 is an FDA 510(k) clearance for the KENDRICK EXTRICATION DEVICE. This device is classified as a Orthosis, Cervical-thoracic, Rigid (Class I - General Controls, product code IQF).

Submitted by Medi-Ked, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 27, 1978, 11 days after receiving the submission on October 16, 1978.

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

Submission Details

510(k) Number K781761 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 16, 1978
Decision Date October 27, 1978
Days to Decision 11 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary

Device Classification

Product Code IQF — Orthosis, Cervical-thoracic, Rigid
Device Class Class I - General Controls
CFR Regulation 21 CFR 890.3490