Cleared Traditional

K896043 - MATTRESS COVER FOR MEDICAL PURPOSES (FDA 510(k) Clearance)

K896043 · Keystone Veterinary Supplies, Inc. · General Hospital

Jan 1990

Decision

86d

Days

Class 1

Risk

K896043 is an FDA 510(k) clearance for the MATTRESS COVER FOR MEDICAL PURPOSES. This device is classified as a Bedding, Disposable, Medical (Class I - General Controls, product code KME).

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 General Hospital FDA review panel. Regulated under 21 CFR 880.6060.

Submission Details

510(k) Number	K896043 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	General Hospital (HO)
Summary	—