Cleared Traditional

FILTERED EXTENSION SETS

K942988 · B. Braun of America, Inc. · General Hospital
Jul 1995
Decision
389d
Days
Class 2
Risk

About This 510(k) Submission

K942988 is an FDA 510(k) clearance for the FILTERED EXTENSION SETS, a Set, Administration, Intravascular (Class II — Special Controls, product code FPA), submitted by B. Braun of America, Inc. (Bethlehem, US). The FDA issued a Cleared decision on July 14, 1995, 389 days after receiving the submission on June 20, 1994. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K942988 FDA.gov
FDA Decision Cleared SESE
Date Received June 20, 1994
Decision Date July 14, 1995
Days to Decision 389 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FPA — Set, Administration, Intravascular
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5440

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