Cleared Traditional

DISPENSING PIN WITH ONE-WAY VALVE

K943181 · B. Braun of America, Inc. · General Hospital
Sep 1994
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K943181 is an FDA 510(k) clearance for the DISPENSING PIN WITH ONE-WAY VALVE, a Set, I.v. Fluid Transfer (Class II — Special Controls, product code LHI), submitted by B. Braun of America, Inc. (Bethlehem, US). The FDA issued a Cleared decision on September 29, 1994, 90 days after receiving the submission on July 1, 1994. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K943181 FDA.gov
FDA Decision Cleared SESE
Date Received July 01, 1994
Decision Date September 29, 1994
Days to Decision 90 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code LHI — Set, I.v. Fluid Transfer
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5440

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