Cleared Traditional

UPPER EXTERMITY DRAPE KIT

K923960 · Medikmark, Inc. · General Hospital
Oct 1994
Decision
792d
Days
Class 2
Risk

About This 510(k) Submission

K923960 is an FDA 510(k) clearance for the UPPER EXTERMITY DRAPE KIT, a Drape, Surgical (Class II — Special Controls, product code KKX), submitted by Medikmark, Inc. (Chicago, US). The FDA issued a Cleared decision on October 7, 1994, 792 days after receiving the submission on August 6, 1992. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4370.

Submission Details

510(k) Number K923960 FDA.gov
FDA Decision Cleared SESE
Date Received August 06, 1992
Decision Date October 07, 1994
Days to Decision 792 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement

Device Classification

Product Code KKX — Drape, Surgical
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.4370

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