Cleared Traditional

EMS I.V. START KIT

K951167 · Emergency Medical Supply, Inc. · General & Plastic Surgery
May 1995
Decision
63d
Days
Class 2
Risk

About This 510(k) Submission

K951167 is an FDA 510(k) clearance for the EMS I.V. START KIT, a I.v. Start Kit (Class II — Special Controls, product code LRS), submitted by Emergency Medical Supply, Inc. (Shepherdsville, US). The FDA issued a Cleared decision on May 16, 1995, 63 days after receiving the submission on March 14, 1995. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 880.5200.

Submission Details

510(k) Number K951167 FDA.gov
FDA Decision Cleared SN
Date Received March 14, 1995
Decision Date May 16, 1995
Days to Decision 63 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary —

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.