Cleared Traditional

HOSPITAL KIT ENT 1125

K922126 · Savoy Medical Supply Co., Inc. · General & Plastic Surgery
Jan 1993
Decision
260d
Days
Class 1
Risk

About This 510(k) Submission

K922126 is an FDA 510(k) clearance for the HOSPITAL KIT ENT 1125, a Tray, Surgical (Class I — General Controls, product code LRP), submitted by Savoy Medical Supply Co., Inc. (Valley Stream, US). The FDA issued a Cleared decision on January 21, 1993, 260 days after receiving the submission on May 6, 1992. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number K922126 FDA.gov
FDA Decision Cleared SESE
Date Received May 06, 1992
Decision Date January 21, 1993
Days to Decision 260 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement

Device Classification

Product Code LRP — Tray, Surgical
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4800