Cleared Special

DRAPES WITH ABSORBENT REINFORCEMENT

K023425 · Allegiance Healthcare Corp. · General Hospital
Nov 2002
Decision
26d
Days
Class 2
Risk

About This 510(k) Submission

K023425 is an FDA 510(k) clearance for the DRAPES WITH ABSORBENT REINFORCEMENT, a Drape, Surgical (Class II — Special Controls, product code KKX), submitted by Allegiance Healthcare Corp. (Mcgaw Park, US). The FDA issued a Cleared decision on November 6, 2002, 26 days after receiving the submission on October 11, 2002. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4370.

Submission Details

510(k) Number K023425 FDA.gov
FDA Decision Cleared SESE
Date Received October 11, 2002
Decision Date November 06, 2002
Days to Decision 26 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

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

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