Cleared Traditional

LEOCOR CORFLO PUMP -- MODIFICATION

K924110 · Leocor, Inc. · General Hospital

Sep 1992

Decision

90d

Days

Class 2

Risk

About This 510(k) Submission

K924110 is an FDA 510(k) clearance for the LEOCOR CORFLO PUMP -- MODIFICATION, a Withdrawal/infusion Pump (Class II — Special Controls, product code DQI), submitted by Leocor, Inc. (Houston, US). The FDA issued a Cleared decision on September 1, 1992, 90 days after receiving the submission on June 3, 1992. This device falls under the General Hospital review panel. Regulated under 21 CFR 870.1800.

Submission Details

510(k) Number	K924110 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 03, 1992
Decision Date	September 01, 1992
Days to Decision	90 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Statement