Cleared Traditional

K896042 - MEDICAL DISPOSABLE BEDDING
(FDA 510(k) Clearance)

Jan 1990
Decision
86d
Days
Class 1
Risk

K896042 is an FDA 510(k) clearance for the MEDICAL DISPOSABLE BEDDING. This device is classified as a Orthosis, Cervical (Class I - General Controls, product code IQK).

Submitted by Keystone Veterinary Supplies, Inc. (Blackwood, US). The FDA issued a Cleared decision on January 10, 1990, 86 days after receiving the submission on October 16, 1989.

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

Submission Details

510(k) Number K896042 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 16, 1989
Decision Date January 10, 1990
Days to Decision 86 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary

Device Classification

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