Cleared Traditional

ANSPACH IRRIGATION PUMP AND IRRIGATION PUMP II

K030576 · The Anspach Effort, Inc. · General Hospital
May 2003
Decision
86d
Days
Class 2
Risk

About This 510(k) Submission

K030576 is an FDA 510(k) clearance for the ANSPACH IRRIGATION PUMP AND IRRIGATION PUMP II, a Pump, Infusion (Class II — Special Controls, product code FRN), submitted by The Anspach Effort, Inc. (Palm Beach Gardens, US). The FDA issued a Cleared decision on May 21, 2003, 86 days after receiving the submission on February 24, 2003. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number K030576 FDA.gov
FDA Decision Cleared SESE
Date Received February 24, 2003
Decision Date May 21, 2003
Days to Decision 86 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FRN — Pump, Infusion
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5725

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