Cleared Traditional

DEROYAL SURGICAL, UMBILICUP

K020753 · Deroyal · Hematology

Jun 2002

Decision

98d

Days

Class 2

Risk

About This 510(k) Submission

K020753 is an FDA 510(k) clearance for the DEROYAL SURGICAL, UMBILICUP, a Container, Empty, For Collection & Processing Of Blood & Blood Components (Class II — Special Controls, product code KSR), submitted by Deroyal (Knoxville, US). The FDA issued a Cleared decision on June 13, 2002, 98 days after receiving the submission on March 7, 2002. This device falls under the Hematology review panel. Regulated under 21 CFR 864.9100.

Submission Details

510(k) Number	K020753 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 07, 2002
Decision Date	June 13, 2002
Days to Decision	98 days
Submission Type	Traditional
Review Panel	Hematology (HE)
Summary	Statement

Device Classification

Product Code	KSR — Container, Empty, For Collection & Processing Of Blood & Blood Components
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 864.9100