Cleared Traditional

HEATED INSTRUMENT BATH

K870276 · Simpson/Basye, Inc. · General Hospital
May 1987
Decision
100d
Days
Class 1
Risk

About This 510(k) Submission

K870276 is an FDA 510(k) clearance for the HEATED INSTRUMENT BATH, a Disinfectant, Medical Devices (Class I — General Controls, product code LRJ), submitted by Simpson/Basye, Inc. (Wilmington, US). The FDA issued a Cleared decision on May 7, 1987, 100 days after receiving the submission on January 27, 1987. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6890.

Submission Details

510(k) Number K870276 FDA.gov
FDA Decision Cleared SESE
Date Received January 27, 1987
Decision Date May 07, 1987
Days to Decision 100 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary —

Device Classification

Product Code LRJ — Disinfectant, Medical Devices
Device Class Class I — General Controls
CFR Regulation 21 CFR 880.6890