Cleared Traditional

CONTAIN-OR

K934215 · Dlp, Inc. · General Hospital
Feb 1994
Decision
163d
Days
Class 2
Risk

About This 510(k) Submission

K934215 is an FDA 510(k) clearance for the CONTAIN-OR, a Drape, Surgical (Class II — Special Controls, product code KKX), submitted by Dlp, Inc. (Grand Rapids, US). The FDA issued a Cleared decision on February 9, 1994, 163 days after receiving the submission on August 30, 1993. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4370.

Submission Details

510(k) Number K934215 FDA.gov
FDA Decision Cleared SESE
Date Received August 30, 1993
Decision Date February 09, 1994
Days to Decision 163 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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