Cleared Traditional

AMSINO I.V. ADMINISTRATION SET

K973107 · Amsino Intl., Inc. · General Hospital
Oct 1997
Decision
44d
Days
Class 2
Risk

About This 510(k) Submission

K973107 is an FDA 510(k) clearance for the AMSINO I.V. ADMINISTRATION SET, a Set, Administration, Intravascular (Class II — Special Controls, product code FPA), submitted by Amsino Intl., Inc. (Pomona, US). The FDA issued a Cleared decision on October 2, 1997, 44 days after receiving the submission on August 19, 1997. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K973107 FDA.gov
FDA Decision Cleared SESE
Date Received August 19, 1997
Decision Date October 02, 1997
Days to Decision 44 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement

Device Classification

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

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