Cleared Traditional

EMPOWER TRANSFER SET, (CAT. NO. 7725)

K041178 · E-Z-Em, Inc. · General Hospital
Jul 2004
Decision
72d
Days
Class 2
Risk

About This 510(k) Submission

K041178 is an FDA 510(k) clearance for the EMPOWER TRANSFER SET, (CAT. NO. 7725), a Tubing, Fluid Delivery (Class II — Special Controls, product code FPK), submitted by E-Z-Em, Inc. (Westbury, US). The FDA issued a Cleared decision on July 16, 2004, 72 days after receiving the submission on May 5, 2004. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K041178 FDA.gov
FDA Decision Cleared SESE
Date Received May 05, 2004
Decision Date July 16, 2004
Days to Decision 72 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FPK — Tubing, Fluid Delivery
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5440

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