Cleared Traditional

K892877 - CRADLE, HOSPITAL BED CLOTHING
(FDA 510(k) Clearance)

K892877 · Warsaw Orthopedic, Inc. · General Hospital
Jun 1989
Decision
57d
Days
Class 1
Risk

K892877 is an FDA 510(k) clearance for the CRADLE, HOSPITAL BED CLOTHING, a Bed, Manual (Class I — General Controls, product code FNJ), submitted by Warsaw Orthopedic, Inc. (Warsaw, US). The FDA issued a Cleared decision on June 15, 1989, 57 days after receiving the submission on April 19, 1989. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5120.

Submission Details

510(k) Number K892877 FDA.gov
FDA Decision Cleared SESE
Date Received April 19, 1989
Decision Date June 15, 1989
Days to Decision 57 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary —

Device Classification

Product Code FNJ — Bed, Manual
Device Class Class I — General Controls
CFR Regulation 21 CFR 880.5120