Cleared Traditional

AMSINO I.V. START KIT

K050654 · Amsino International, Inc. · General & Plastic Surgery
May 2005
Decision
49d
Days
Class 2
Risk

About This 510(k) Submission

K050654 is an FDA 510(k) clearance for the AMSINO I.V. START KIT, a I.v. Start Kit (Class II — Special Controls, product code LRS), submitted by Amsino International, Inc. (Pomona, US). The FDA issued a Cleared decision on May 2, 2005, 49 days after receiving the submission on March 14, 2005. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 880.5200.

Submission Details

510(k) Number K050654 FDA.gov
FDA Decision Cleared SESE
Date Received March 14, 2005
Decision Date May 02, 2005
Days to Decision 49 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement

Device Classification

Product Code LRS — I.v. Start Kit
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5200
Definition This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm080217.pdf. This Type Of Convenience Kit, As Listed In The Guidance Above, Is Under Enforcement Discretion, And Does Not Require A Premarket Notification (510(k)) To Market If It Meets All Criteria In The Guidance.