Cleared Traditional

CONTINU-FLO SOLUTION ADMIN. SET W/IN-LINE FILTER

K865029 · Travenol Laboratories, S.A. · General Hospital
Apr 1987
Decision
115d
Days
Class 2
Risk

About This 510(k) Submission

K865029 is an FDA 510(k) clearance for the CONTINU-FLO SOLUTION ADMIN. SET W/IN-LINE FILTER, a Filter, Infusion Line (Class II — Special Controls, product code FPB), submitted by Travenol Laboratories, S.A. (Round Lake, US). The FDA issued a Cleared decision on April 17, 1987, 115 days after receiving the submission on December 23, 1986. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K865029 FDA.gov
FDA Decision Cleared SESE
Date Received December 23, 1986
Decision Date April 17, 1987
Days to Decision 115 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary —

Device Classification

Product Code FPB — Filter, Infusion Line
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5440

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