Cleared Traditional

RESUBMITTED MICRON TRANSFUSION FILTER

K873873 · Travenol Laboratories, S.A. · General Hospital
Oct 1987
Decision
52d
Days
Class 2
Risk

About This 510(k) Submission

K873873 is an FDA 510(k) clearance for the RESUBMITTED MICRON TRANSFUSION FILTER, a Microfilter, Blood Transfusion (Class II — Special Controls, product code CAK), submitted by Travenol Laboratories, S.A. (Round Lake, US). The FDA issued a Cleared decision on October 22, 1987, 52 days after receiving the submission on August 31, 1987. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K873873 FDA.gov
FDA Decision Cleared SESE
Date Received August 31, 1987
Decision Date October 22, 1987
Days to Decision 52 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary —

Device Classification

Product Code CAK — Microfilter, Blood Transfusion
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5440

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