Cleared Traditional

CHARTER MEDICAL, LTD MP 450 (40 MICRON FILTER)

K990310 · Charter Medical, Ltd. · General Hospital

Aug 1999

Decision

210d

Days

Class 2

Risk

About This 510(k) Submission

K990310 is an FDA 510(k) clearance for the CHARTER MEDICAL, LTD MP 450 (40 MICRON FILTER), a Microfilter, Blood Transfusion (Class II — Special Controls, product code CAK), submitted by Charter Medical, Ltd. (Lakewood, US). The FDA issued a Cleared decision on August 30, 1999, 210 days after receiving the submission on February 1, 1999. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number	K990310 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 01, 1999
Decision Date	August 30, 1999
Days to Decision	210 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF