Cleared Traditional

0.2 U BACTERIAL FILTER

K974661 · Sims Deltec, Inc. · General Hospital
Feb 1998
Decision
58d
Days
Class 2
Risk

About This 510(k) Submission

K974661 is an FDA 510(k) clearance for the 0.2 U BACTERIAL FILTER, a Filter, Infusion Line (Class II — Special Controls, product code FPB), submitted by Sims Deltec, Inc. (St. Paul, US). The FDA issued a Cleared decision on February 11, 1998, 58 days after receiving the submission on December 15, 1997. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K974661 FDA.gov
FDA Decision Cleared SESE
Date Received December 15, 1997
Decision Date February 11, 1998
Days to Decision 58 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

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

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