Cleared Traditional

WOUND DRESSING KIT

K941467 · Clinical Resources, Inc. · General Hospital
May 1994
Decision
45d
Days
Class 2
Risk

About This 510(k) Submission

K941467 is an FDA 510(k) clearance for the WOUND DRESSING KIT, a Wrap, Sterilization (Class II — Special Controls, product code FRG), submitted by Clinical Resources, Inc. (Elgin, US). The FDA issued a Cleared decision on May 12, 1994, 45 days after receiving the submission on March 28, 1994. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6850.

Submission Details

510(k) Number K941467 FDA.gov
FDA Decision Cleared SESE
Date Received March 28, 1994
Decision Date May 12, 1994
Days to Decision 45 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement

Device Classification

Product Code FRG — Wrap, Sterilization
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.6850

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